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

Job Opportunity

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

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

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.