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Engineering Jobs

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

Pharmavise Corporation

  • Saint Paul, Minnesota
  • 30+ days ago

    Highlights

    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. • 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.

    Numbers & Facts

    LocationSaint Paul, Minnesota
    Websitehttp://www.pharmavise.com

    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 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

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