Manager, Quality Engineering

Role: Manager, Quality Engineering, leading quality support for manufacturing, product development, validation, and risk management in a biopharma or medical device manufacturing setting. Responsibilities: oversee nonconformance, CAPAs, customer complaints, process validation, and technical investigations; develop and lead a team of quality engineers; support process improvements, validation, and regulatory compliance activities; participate in audits and technical documentation for regulatory submissions. Requirements: BS in Engineering or Science; 7-10 years in quality assurance/engineering, validation, or related fields supporting manufacturing; strong knowledge of GMP, FDA, ISO 13485, ISO 14971, risk management, and validation standards; ASQ/CQE certification preferred; excellent communication skills. High-Value: medical device or biopharma manufacturing, validation, risk mitigation, FDA and ISO standards, regulatory audit support, cross-functional collaboration. WorkSetup: not specified; likely an on-site or hybrid environment with minimal supervision.