Quality Engineer I — Medical Devices (Onsite)

Pharmavise Corporation; Saint Paul (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality System Regulations

Medical Device Regulation

ISO 13485

Microsoft Word

Microsoft Excel

Microsoft Outlook

Attention to detail

Writing & communication

Critical thinking

Education

Bachelor's degree in Engineering

Tools

SAP

MES

TrackWise

Job description

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.