Quality Engineer

Job Title: Quality Engineer

Location: Arden Hills, MN 55126

Duration: 12 Months Contract with Possible of extension

Job Description:

• The candidate will serve as a second set of eyes on complaint investigations, reviewing investigator work to ensure investigations are complete, logical, and well‑supported.
• A successful candidate is able to analyze information critically, identify gaps or inconsistencies, and clearly communicate feedback to investigators to strengthen the overall investigation narrative and conclusions.
• 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