Job Description
Insight Global is seeking a Quality Engineer (Process Validation) to support a leading medical device client in a highly regulated manufacturing environment. This role will focus on executing process validations (IQ, OQ, PQ) and providing hands-on support on the manufacturing floor to troubleshoot and resolve quality and process issues. The ideal candidate has a few years of validation experience, thrives in fast-paced production settings, and is comfortable collaborating cross-functionally to ensure compliant, efficient manufacturing operations.
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/.
Required Skills & Experience
1–5+ years of experience in medical device manufacturing or another highly regulated industry
Hands-on experience executing process validations including IQ, OQ, PQ
Strong understanding of GMP, FDA, ISO 13485, and regulated quality systems
Experience investigating non-conformances, deviations, and supporting CAPAs
Experience supporting or executing change control activities
Nice to Have Skills & Experience
Experience supporting new product introductions (NPI)
Exposure to EU MDR validation assessment or rationalization
Experience with PLM systems
Background in orthopedic, casting, or implantable medical devices
Benefit packages for this role will start on the 1st 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.