Senior Quality Engineer

Skill Requirements

• 5+ years in Quality Engineering / QA within medical devices or regulated manufacturing
• Strong experience with CAPA, investigations, complaints, and QMS
• Knowledge of ISO 13485, ISO 9001, and GMP environments
• Previous leadership experience or strong cross-functional leadership capability
• Data-driven mindset with experience in statistical analysis, Lean, or Six Sigma

Responsibilities

• Lead and own quality events, CAPA, and investigations, ensuring robust root cause analysis and closure
• Drive complaint handling and defect resolution, including customer communication and trend analysis
• Provide cross-functional leadership on non-conformances, containment, and corrective actions
• Apply Lean, Six Sigma, and data-driven problem solving to improve quality and reduce defects
• Support new product introduction (NPI) and process improvements
• Develop and lead a high-performing Quality Engineering team