Jobs → QA & Testing → QA Manager

About the Role We are seeking a senior-level QA Manager with strong medical device industry experience to support the development and manufacturing of a portable electromechanical medical device with embedded software. Key Responsibilities • Develop quality plans and strategies for medical device development and manufacturing • Manage risk assessment and risk management activities in compliance with ISO 14971 • Coordinate Design Verification & Validation (V&V) test plans and Requirements Traceability Matrices • Ensure compliance with medical device GMPs, ISO 13485, and applicable quality standards • Coordinate electrical safety, biocompatibility, and cleaning and disinfection testing with external vendors • Prepare and maintain Design History Files (DHF) and Device Master Records (DMR) • Develop process validation plans and coordinate supplier qualification activities • Support PFMEAs, failure analysis, and resolution of quality issues • Provide technical guidance and collaborate with cross-functional project teams Requirements • Strong medical device industry experience • Knowledge of Quality Management Systems (QMS) • Expertise in medical device GMPs and ISO 13485 • Experience in design controls, risk management, and product development • 10+ years of experience preferred • Ability to make independent technical decisions and manage multiple projects Preferred Skills • ISO 14971 – Risk Management • IEC 60601 – Medical Electrical Equipment Safety • IEC 62304 – Medical Device Software • Experience with Empower and Omnify systems • Supplier Quality and Process Validation