Quality Engineer - Medical Device; Onsite - Arden Hills, MN Extension

Position: Quality Engineer I - Medical Device (Onsite - Arden Hills, MN) Possible Contract Extension
Job Description
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 ISO
13485 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 Track Wise