What are the responsibilities and job description for the Quality Engineer I — Medical Device (Onsite — Arden Hills, MN) Possible Contract Extension position at Pharmavise Corporation?
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
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