Principal Quality Engineer

About the role

CooperSurgical is seeking a Principal Quality Engineer to provide advanced QA support and technical leadership for its MEVS operations. The role ensures that quality systems are effectively implemented, continuously improved, and aligned with regulatory requirements.

Key responsibilities

• Lead complex investigations, NCMRs, and CAPAs, including root‑cause analysis, risk assessment, and effectiveness verification.
• Ensure compliance with 21 CFR 820, QMSR, ISO 13485, ISO 13408, and EU MDR, translating requirements into practical execution.
• Support inspection readiness, providing expertise during audits and responding to findings.
• Partner with Manufacturing, Engineering, QC, Supply Chain, and R&D to resolve quality issues and improve process capability.
• Analyze and trend quality data, identify risks, and recommend improvements to site leadership.
• Contribute to product disposition decisions through data review and risk assessment.
• Mentor junior quality staff and assist in Management Review preparation.
• Participate in external audits, supplier engagements, and limited industry activities.

Required profile

• Expert knowledge of 21 CFR 820, QMSR, ISO 13485, ISO 13408, and EU MDR.
• Strong background in aseptic processing and sterility assurance, including contamination control and environmental monitoring.
• Proven experience leading investigations, deviations, and CAPA programs with robust root‑cause analysis.
• Ability to translate regulatory requirements into actionable quality system improvements.
• Excellent analytical skills for data trending and risk assessment.

Required skills

• 21 CFR 820
• QMSR
• ISO 13485
• ISO 13408
• EU MDR
• Aseptic processing
• Sterility assurance
• Contamination control
• Environmental monitoring
• Media fill / aseptic process simulation
• Root‑cause analysis
• CAPA management
• Risk assessment
• Investigation of nonconformances
• Data analysis and trend reporting