Quality Engineer II

About the role

CooperSurgical is seeking a Quality Engineer II to lead and support quality engineering activities across its manufacturing processes. The role focuses on ensuring product quality, regulatory compliance, and continuous improvement within a fast‑growing medical‑device environment.

Key responsibilities

• Lead process validation, equipment qualification (IQ/OQ/PQ) and change management activities.
• Conduct root‑cause investigations and drive CAPA implementation using structured problem‑solving methods.
• Manage nonconformance and deviation investigations, documentation, and disposition per quality system requirements.
• Maintain aseptic processing knowledge and apply contamination control strategies.
• Support internal and external audits, representing Quality Assurance as a subject‑matter expert.
• Analyze quality metrics, identify trends and lead Lean or Six Sigma improvement projects.
• Mentor junior engineers and inspectors, and collaborate with Manufacturing, R&D, Supply Chain, Regulatory Affairs and other functions.
• Participate in supplier qualification, performance monitoring and issue resolution.
• Serve as quality representative on NPI, design transfer and scale‑up teams.

Required profile

• Strong understanding of ISO 13485, ISO 13408, EU MDR, MDSAP and other global medical‑device standards.
• Proven ability to work in a matrixed organization and build relationships at all levels.
• Hands‑on experience with process validation, CAPA, nonconformance management and change control.
• Excellent time‑management, organizational and communication skills.

Required skills

• ISO 13485
• ISO 13408
• EU MDR
• MDSAP
• Process validation
• CAPA methodology
• Nonconformance management
• Change control
• Lean Six Sigma
• Aseptic processing concepts