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Feb 26, 2026

Chelmsford, MA

|

Mechanical Engineering

|

Contract

|

$34 - $42 (hourly estimate)

{"JobID":499803,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-71.3647,"Longitude":42.6233,"Distance":null},"State":"Massachusetts","Zip":"01824","ReferenceID":"BOS-ffc14237-75cc-4d19-83ea-c11fbb8c9915","PostedDate":"\/Date(1772110774000)\/","Description":"Insight Global is seeking a Facilities Technician for one of their top semiconductor clients. This person will work the 2nd shift from 3:00PM - 11:30 PM M-F. This person will play a key role in maintaining the smooth and safe operation of all building systems. This role is responsible for troubleshooting, repairing, and performing preventive maintenance on HVAC systems while also providing general facilities support across plumbing, electrical, carpentry, and daily operational tasks. The ideal candidate is a hands-on problem solver who can work both independently and collaboratively within a fast-paced environment.Key Responsibilities: HVAC Maintenance \u0026 RepairPerform routine and seasonal preventive maintenance to ensure equipment reliability.General Facilities Support Assist with basic plumbing and electrical repairs (e.g., fixtures, switches, minor wiring tasks).Support modular furniture installs, moves, and repairs.Perform light carpentry work including fixing locks, doors, and minor structural components.Operational DutiesConduct facility rounds to check equipment status and overall building conditions.Respond to service tickets promptly and ensure accurate documentation of work performed.Use QR codes and digital tools to update equipment history, maintenance logs, and asset data.Follow all safety protocols, ensuring compliance with internal and regulatory standards.Pay for this position is $25 - 38/hr based on qualifications and years of experienceWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"2nd Shift Facilities Technician","City":"Chelmsford","ExpirationDate":null,"PriorityOrder":0,"Requirements":"- 5 years of experience- HVAC Experience- Experience with basic plumbing and electrical systems.- Basic carpentry experience - Experience working on electrical systems - Experience with modular furniture- Ability to work both independently and as part of a cross-functional team.- Strong problem-solving skills and a customer-focused mindset.","Skills":"Safety certifications (e.g., OSHA 10, lockout/tagout) or previous safety training.Experience in lab environments or regulated industries such as pharmaceutical, semiconductor, or solar manufacturing.","Industry":"Mechanical Engineering","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":42.0000,"SalaryLow":33.6000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is seeking a Facilities Technician for one of their top semiconductor clients. This person will work the 2nd shift from 3:00PM - 11:30 PM M-F. This person will play a key role in... maintaining the smooth and safe operation of all building systems. This role is responsible for troubleshooting, repairing, and performing preventive maintenance on HVAC systems while also providing general facilities support across plumbing, electrical, carpentry, and daily operational tasks. The ideal candidate is a hands-on problem solver who can work both independently and collaboratively within a fast-paced environment.Key Responsibilities: HVAC Maintenance & RepairPerform routine and seasonal preventive maintenance to ensure equipment reliability.General Facilities Support Assist with basic plumbing and electrical repairs (e.g., fixtures, switches, minor wiring tasks).Support modular furniture installs, moves, and repairs.Perform light carpentry work including fixing locks, doors, and minor structural components.Operational DutiesConduct facility rounds to check equipment status and overall building conditions.Respond to service tickets promptly and ensure accurate documentation of work performed.Use QR codes and digital tools to update equipment history, maintenance logs, and asset data.Follow all safety protocols, ensuring compliance with internal and regulatory standards.Pay for this position is $25 - 38/hr based on qualifications and years of experienceWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Jun 04, 2026

New York, NY

|

Engineering (Non IT)

|

Contract

|

$53 - $66 (hourly estimate)

{"JobID":537808,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-73.87,"Longitude":40.84,"Distance":null},"State":"New York","Zip":"10457","ReferenceID":"GRR-d703f9b5-fdcf-4e80-b941-d3020a9b6d74","PostedDate":"\/Date(1780585875000)\/","Description":"A client of Insight Global in the Bronx, NY is seeking a Project Engineer to join their team. This individual will be responsible for leading capital projects related to facility initiatives, including HVAC upgrades, facility airflow improvements, Building Management Systems, ductwork, and more. Project budgets can range from $200K to $1M+. Timelines and scopes will vary; this individual must be able to lead cross-functional teams from design through delivery. The ideal candidate must also be willing to support hands-on engineering and problem-solving when needed. Consistent communication with various business groups, executive leadership, and vendors is required. This is an onsite position, and candidates must be able to work onsite five days per week.Compensation:$62/hr to $66/hrExact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Project Engineer","City":"New York","ExpirationDate":null,"PriorityOrder":0,"Requirements":"- Bachelor?s degree in Engineering (Mechanical preferred, Electrical or related considered)- 8+ years of experience as an engineer in a GMP manufacturing environment- Direct facility/utility systems experience (purified water, HVAC, air balancing, BMS, ductwork, etc.)- Experience leading capital projects with cross functional teams (managing scope, budgets, and timelines)","Skills":"- Experience with MS Project- FDA or pharmaceutical industry experience- Experience leading capital projects with $1M+ in budget at a single time","Industry":"Engineering (Non IT)","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":66.0000,"SalaryLow":52.8000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

A client of Insight Global in the Bronx, NY is seeking a Project Engineer to join their team. This individual will be responsible for leading capital projects related to facility initiatives,... including HVAC upgrades, facility airflow improvements, Building Management Systems, ductwork, and more. Project budgets can range from $200K to $1M+. Timelines and scopes will vary; this individual must be able to lead cross-functional teams from design through delivery. The ideal candidate must also be willing to support hands-on engineering and problem-solving when needed. Consistent communication with various business groups, executive leadership, and vendors is required. This is an onsite position, and candidates must be able to work onsite five days per week.Compensation:$62/hr to $66/hrExact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Apr 14, 2026

Santa Clara, CA

|

QA

|

Contract

|

$64 - $80 (hourly estimate)

{"JobID":518402,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-121.96,"Longitude":37.39,"Distance":null},"State":"California","Zip":"95054","ReferenceID":"SJC-0dc3fbca-259f-4bc7-adbc-6b7fea385881","PostedDate":"\/Date(1776127150000)\/","Description":"Insight Global is seeking a Configuration Admin will oversee the implementation of a new configuration management and manufacturing BOM change control process for one of our Supply Chain clients. This individual will help with ensuring compliant impact assessments and risk analyses, coordinating with R\u0026D and Quality on implementation, maintaining change records, and reporting metrics to monitor cycle times and support quality initiatives.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"BOM Configuration Administrator","City":"Santa Clara","ExpirationDate":null,"PriorityOrder":0,"Requirements":"?5-8 years QA experience in regulated medical device or pharmaceutical environments, with strong knowledge of ISO 13485 \u0026 Quality Management System (QMS) requirements, specifically supporting the change management process?Strong knowledge of formal change management processes, including impact assessments, risk evaluation, documentation, approvals, and change closure.?Experience supporting change implementation for products or processes transitioning from R\u0026D to manufacturing.?Experience leading Change Review Boards (CRB) and ensuring cross functional stakeholder participation.","Skills":"","Industry":"QA","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":80.0000,"SalaryLow":64.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is seeking a Configuration Admin will oversee the implementation of a new configuration management and manufacturing BOM change control process for one of our Supply Chain clients.... This individual will help with ensuring compliant impact assessments and risk analyses, coordinating with R&D and Quality on implementation, maintaining change records, and reporting metrics to monitor cycle times and support quality initiatives.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Apr 24, 2026

Raynham, MA

|

Engineering (Non IT)

|

Contract-to-perm

|

$57 - $71 (hourly estimate)

{"JobID":522891,"JobType":["Contract-to-perm"],"EmployerID":null,"Location":{"Latitude":-71.0459,"Longitude":41.9291,"Distance":null},"State":"Massachusetts","Zip":"02767","ReferenceID":"BOS-0d50ba83-a0b7-4568-9cd3-307748bba90d","PostedDate":"\/Date(1777036386000)\/","Description":"Insight Global is seeking a Packaging Engineer for a top regulated manufacturing client. This role will support critical labeling and packaging initiatives with a strong emphasis on packaging roadmap development, supplier coordination, and sustainability-driven material transitions. The ideal candidate will play a hands-on role in eliminating P-FAST materials, transitioning blister packaging to pouch-based solutions, and coordinating execution plans across cross-functional teams. This is an excellent opportunity for a packaging professional who enjoys project coordination, supplier interaction, and driving meaningful sustainability improvements within a regulated environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Packaging Engineer","City":"Raynham","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor?s degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical fieldSolid understanding of packaging materials, formats, and systemsExperience with medical device, pharmaceutical, or other regulated manufacturing environmentsStrong communication and interpersonal skillsAbility to coordinate across cross-functional teams (packaging, labeling, manufacturing, quality, supply chain)Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)Experience supporting packaging or labeling changesAbility to manage timelines, documentation, and deliverables (project coordination focus)","Skills":"Experience with blister packaging, pouches, and plastic packaging materialsExperience transitioning packaging formats Familiarity with Windchill or similar PLM systemsExposure to sustainability initiatives or carbon-reduction packaging effortsExperience working directly with external suppliersManufacturing floor exposure and troubleshooting experienceExperience implementing recycling symbol or resin identification code updates","Industry":"Engineering (Non IT)","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":71.0000,"SalaryLow":56.8000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is seeking a Packaging Engineer for a top regulated manufacturing client. This role will support critical labeling and packaging initiatives with a strong emphasis on packaging roadmap... development, supplier coordination, and sustainability-driven material transitions. The ideal candidate will play a hands-on role in eliminating P-FAST materials, transitioning blister packaging to pouch-based solutions, and coordinating execution plans across cross-functional teams. This is an excellent opportunity for a packaging professional who enjoys project coordination, supplier interaction, and driving meaningful sustainability improvements within a regulated environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Jan 16, 2026

Mundelein, IL

|

Administrative Assistant

|

Contract

|

$20 - $25 (hourly estimate)

{"JobID":483956,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-e46cf710-aae7-4b14-84b2-4ce6d4012725","PostedDate":"\/Date(1768605073000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.1+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":25.0000,"SalaryLow":20.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Mar 18, 2026

Mundelein, IL

|

Administrative Assistant

|

Contract

|

$32 - $40 (hourly estimate)

{"JobID":508381,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-4c112355-7038-4592-9b38-f4ce0745c5cb","PostedDate":"\/Date(1773871227000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.5+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.5+ years of hands-on experience working in a clinical setting, such as a BSN or RN background with direct patient care experience in high-acuity environments including ICU, PCU, ER, or Operating Room units.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":40.0000,"SalaryLow":32.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

May 08, 2026

Northfield, IL

|

Engineering (Non IT)

|

Contract

|

$38 - $47 (hourly estimate)

{"JobID":528246,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-87.74,"Longitude":42.1,"Distance":null},"State":"Illinois","Zip":"60093","ReferenceID":"CHI-22c9d77c-a925-471d-aa85-cf67f8c40ff1","PostedDate":"\/Date(1778248913000)\/","Description":"Insight Global is seeking an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR?s, product specifications, design control files, and CE technical files.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Quality Engineer","City":"Northfield","ExpirationDate":null,"PriorityOrder":0,"Requirements":"3-5+ years of experience as a Quality Engineer, Design Engineer, or Quality System Engineer within medical devices, pharmaceutical, or regulated healthcare manufacturing.Strong working knowledge of 21 CFR Part 820 and/or ISO 13485Hands on experience supporting Device Master Record (DMR) and Design History Files (DHF), or similar risk management design maintenance, execution, or remediation.Familiarity with Corrective Action Preventative Action (CAPA)Skills: Adaptive to change, cross-functionally collaborative, strong time management skills, independent, problem solver, self-motivatedSystems: Reliance or similar QMS","Skills":"","Industry":"Engineering (Non IT)","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":47.0000,"SalaryLow":37.6000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is seeking an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional... support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR?s, product specifications, design control files, and CE technical files.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

May 04, 2026

Etobicoke, ON

|

Mechanical Engineering

|

Perm

|

$176k - $220k (estimate)

{"JobID":525833,"JobType":["Perm"],"EmployerID":null,"Location":{"Latitude":0,"Longitude":0,"Distance":null},"State":"Ontario","Zip":"M9W 6","ReferenceID":"TOR-68abc213-162b-4115-b7b9-a52f0f311c3a","PostedDate":"\/Date(1777863976000)\/","Description":"**PLEASE DO NOT RECRUIT NOR CREATE JOB POSTINGS WITHOUT PREPPING WITH ME IN ADVANCE**This is a senior-level leadership opportunity for a manufacturing site within a regulated industry. We are seeking a results-oriented leader to oversee plant operations, drive continuous improvement, and manage day-to-day performance across production, packaging, and support functions.The ideal candidate is a strategic, hands-on leader who prioritizes shop-floor presence, employee development, and operational excellence. You will be responsible for ensuring safety, meeting strict quality/compliance standards, and delivering on key operational metrics.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"!!CONFIDENTIAL!! Site Director, Manufacturing","City":"Etobicoke","ExpirationDate":null,"PriorityOrder":0,"Requirements":"? Bachelor?s degree in a relevant Science or Engineering discipline.? 10+ years of experience in a highly regulated manufacturing environment (Pharmaceutical or related).? 5?8 years of senior-level management experience.? Strong experience with the procurement, commissioning, and qualification of manufacturing equipment.? Direct experience with relevant regulatory inspections (e.g., FDA).? Excellent public speaking skills and the ability to engage with large teams effectively.? A \"hands-on\" leadership style with a focus on shop-floor engagement.","Skills":"? Operational Excellence: Oversee daily plant operations to ensure consistent delivery against daily, monthly, and annual output targets. Manage site budget and headcount.? Compliance \u0026 Safety: Maintain a proactive culture of safety and ensure full compliance with regulatory standards and standard operating procedures (SOPs).? People Leadership: Build and sustain a high-performing culture. Lead performance management, employee development, and engagement initiatives across a large, non-unionized workforce.? Strategic Planning: Develop and execute reliability programs and process optimizations to meet future business readiness and growth objectives.? Technical Oversight: Partner with Engineering and Maintenance to assess and implement equipment upgrades to support production efficiency.","Industry":"Mechanical Engineering","Country":"Canada","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":220000.0000,"SalaryLow":176000.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

**PLEASE DO NOT RECRUIT NOR CREATE JOB POSTINGS WITHOUT PREPPING WITH ME IN ADVANCE**This is a senior-level leadership opportunity for a manufacturing site within a regulated industry. We are seeking... a results-oriented leader to oversee plant operations, drive continuous improvement, and manage day-to-day performance across production, packaging, and support functions.The ideal candidate is a strategic, hands-on leader who prioritizes shop-floor presence, employee development, and operational excellence. You will be responsible for ensuring safety, meeting strict quality/compliance standards, and delivering on key operational metrics.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Feb 18, 2026

Mundelein, IL

|

Administrative Assistant

|

Contract

|

$26 - $32 (hourly estimate)

{"JobID":496082,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-03b88789-cfec-4b1a-a4f3-15b6923492e7","PostedDate":"\/Date(1771387674000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.1+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":32.0000,"SalaryLow":25.6000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Mar 16, 2026

Blue Ash, OH

|

Engineering (Non IT)

|

Contract

|

$52 - $65 (hourly estimate)

{"JobID":506878,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-84.51,"Longitude":39.09,"Distance":null},"State":"Ohio","Zip":"45242","ReferenceID":"CIN-60b4c03a-2b82-4a3e-b6f0-ff64c224b4e8","PostedDate":"\/Date(1773672715000)\/","Description":"An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R\u0026R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R\u0026D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Equipment Process Engineer","City":"Blue Ash","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor?s degree in Engineering (Mechanical, Electrical, Manufacturing, Chemical, or related).Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.Strong knowledge of GMPs, validation methodologies, and equipment lifecycle management.3+ years developing custom sterile barrier packaging and boxing equipment and processes (foil-based, bioabsorbable, and moisture-sensitive materials)Hands-on experience with vacuum drying equipment and associated process development and validation.Proven ability to manage external equipment suppliers through design, build, and qualification phases in a regulated environment.Ability to travel domestically once a month to supplier sites","Skills":"medical device certifications","Industry":"Engineering (Non IT)","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":65.0000,"SalaryLow":52.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term... and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

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