Quality Assurance Engineer (Medical Device) Job Description Template

The quality assurance engineer in medical devices maintains the quality management system that makes the product legally marketable. The role spans design controls, supplier quality, nonconformance handling, corrective action and audit readiness. It requires the ability to enforce process without becoming an obstacle, since a quality function that engineers route around is worse than none at all.

Typical Duties and Responsibilities

• Maintain and improve the quality management system
• Support design control activities and review design documentation
• Manage nonconformances, corrective actions and preventive actions
• Conduct internal audits and support external and notified body audits
• Review and approve change controls and their impact assessment
• Support supplier qualification and supplier quality monitoring
• Analyze complaint and post market data for quality trends
• Train staff on quality procedures and their purpose
• Maintain the document control system
• Support regulatory submissions with quality documentation

Education

• Bachelor’s degree in engineering, life sciences or a related field

Required Skills and Experience

• 3+ years in medical device quality assurance
• Working knowledge of ISO 13485 and 21 CFR Part 820
• Experience with corrective and preventive action investigations
• Understanding of design controls and risk management
• Audit experience, internal or external
• Precise written work, since the record is the evidence
• Ability to influence engineers without simply blocking them
• Analytical approach to quality data

Preferred Qualifications

• Certified quality auditor or engineer credential
• Experience with EU MDR