Job Description
These people will add technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data across Interventional Cardiology and Vascular Therapies (ICVT) devices. These members evaluate post‑market surveillance data, including complaints and adverse events, to identify, investigate, and resolve safety or quality issues in compliance with regulatory and internal requirements. They will support product signal escalations by performing root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement. The roles implement compliant process improvements, communicate product performance insights to leadership and design teams, and support performance reporting and customer inquiries. These people maintain a strong commitment to patient safety, product quality, and adherence to the Quality Policy and standards.
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
• Bachelor’s degree in engineering or a related technical or scientific discipline.
• 1 Year of Experience working with Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
Nice to Have Skills & Experience
• Experience in SAP, MES, or TrackWise
• Experience applying critical thinking to ensure investigations are thorough, appropriate, and aligned with procedural and quality requirements.
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.