Jobs and Careers

Quality Engineer I — Medical Device (Onsite — Arden Hills, MN) Possible Contract Extension

Saint Paul, United StatescontractVerifiedPosted 20 Apr 2026

About the role

Job Purpose This 12-month contract role leads technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data to investigate and escalate issues across a range of Interventional Cardiology & Vascular Therapies (ICVT) devices. It involves cross-functional collaboration to drive product and process improvements and enhance investigation outcomes. The position also offers high visibility across site and divisional leadership. Responsibilities: • Analyze post-market surveillance data, including customer complaints and adverse events, to ensure timely identification, investigation, and resolution of safety or quality issues in compliance with regulatory and internal standards. • Lead product signal escalations by conducting root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement. • Collaborate cross-functionally to develop and implement efficient, compliant solutions that enhance Complaint Investigation Site (CIS) processes and support organizational and regulatory goals. • Communicate product performance insights through formal presentations to leadership and design teams, support published performance reports, and respond to customer inquiries directly or via the sales organization. • Uphold a strong commitment to patient safety and product quality by ensuring adherence to the Quality Policy and all relevant procedures and standards. Minimum Requirements: • Bachelor’s degree in Engineering or a related technical or scientific discipline with 0-1 years of relevant experience • Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards. • Proficient in Microsoft Word, Excel, and Outlook • Strong attention to detail • Solid writing and communication skills • Apply critical thinking to ensure investigations are thorough, appropriate, and aligned with procedural and quality requirements. Preferred Requirements: • Experience in SAP, MES, or TrackWise