Complaint / QA Engineer

ENvue Medical; Plymouth (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device company in Plymouth, MN is seeking a QA engineer responsible for managing complaint investigations and ensuring product quality. The ideal candidate has a BSc in Engineering or Life Science with over 3 years of QA experience in the medical field. Join the team to help maintain the highest safety and quality standards in enteral care.

Qualifications

• 3+ years experience in QA, post-market, or CAPA within medical devices.
• Knowledge of ISO 13485 and FDA QSR.

Responsibilities

• Investigate product complaints, document findings, and implement CAPA.
• Perform root cause analysis and trend reporting.
• Maintain risk management files and post-market surveillance records.
• Collaborate with R&D and Operations to drive continuous improvement.

Skills

Investigate product complaints

Document findings

Implement CAPA

Root cause analysis

Trend reporting

Education

BSc in Engineering or Life Science

Job description

We are seeking a QA engineer to manage complaint investigations and corrective actions, ensuring ENvue’s products continuously meet safety and quality standards.

Key Responsibilities

• Investigate product complaints, document findings, and implement CAPA.
• Perform root cause analysis and trend reporting.
• Maintain risk management files and post-market surveillance records.
• Collaborate with R&D and Operations to drive continuous improvement.

Qualifications

• BSc in Engineering or Life Science.
• 3+ years experience in QA, post-market, or CAPA within medical devices.

Preferred Experience

• Knowledge of ISO 13485 and FDA QSR.

Personal Attributes

Structured, analytical, and quality-focused.

Why Join Us

Ensure every product that leaves ENvue maintains our promise of clarity and trust.

About ENvue Medical

ENvue defines where every enteral journey begins - at the point of placement. We are building the foundation of modern enteral care: from navigation and feeding tubes to syringes, sets, pumps, and beyond. Our platform sets the standard for hospitals and extends seamlessly into home care. Join the team shaping the starting point of enteral therapy - and everything that follows.

Location: Minneapolis, MN