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

Pharmavise Corporation; Saint Paul (MN); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Pharmavise Corporation in Arden Hills, MN is seeking a Quality Engineer I for a 12-month, onsite contract focused on post-market complaint investigations across ICVT devices.

You will analyze surveillance data, lead root-cause investigations, and collaborate cross-functionally to improve CIS processes and ensure regulatory compliance. Responsibilities include presenting findings to leadership and supporting CAPA programs.

Formación

• Bachelor's degree in Engineering or related technical/scientific discipline.
• Knowledge of Quality System Regulations and ISO13485 quality standards.
• Proficient with MS Word, Excel, Outlook; strong written and verbal communication.
• Attention to detail with robust investigative writing and analysis.
• Experience applying critical thinking to investigations and regulatory compliance.

Responsabilidades

• Analyze post‑market surveillance data and customer complaints to identify safety/quality issues.
• Lead root-cause investigations and document findings in the quality system.
• Collaborate cross-functionally to develop compliant solutions that improve CIS processes.
• Communicate product performance insights through presentations to leadership and design teams.
• Uphold patient safety and product quality by adhering to Quality Policy and procedures.

Conocimientos

Quality System Regulations

Medical Device Regulation

ISO 13485

Microsoft Word

Microsoft Excel

Microsoft Outlook

Attention to detail

Writing & communication

Critical thinking

Educación

Bachelor's degree in Engineering

Herramientas

SAP

MES

TrackWise

Descripción del empleo

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

Saint Paul, United States | Posted on 04/20/2026

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. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

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 escape 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 escalationsby conducting root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement.
• Collaborate cross-functionallyto develop and implement efficient, compliant solutions that enhance Complaint Investigation Site (CIS) processes and support organizational and regulatory goals.
• Communicate product performance insightsthrough 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 qualityby ensuring adherence to the Quality Policy and all relevant procedures and standards.

Qualifications:

• 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

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.