Senior Quality Engineer- Design Quality – Lifecycle Management

Role: Senior Quality Engineer specializing in Design Quality for Lifecycle Management of medical devices and combination products, overseeing design transfer and change management activities. Responsibilities: ensure compliance with quality systems during product transfer from development to manufacturing, support design control/risk management, manage design history files, lead design transfer for product launches, support equipment qualifications and process validations, author and review regulatory documentation, monitor effectiveness of quality processes, lead audits and investigations, and drive continuous improvement initiatives. Requirements: Bachelor's degree in Biology, Chemistry, Engineering, with 6+ years in manufacturing, quality, or engineering; strong communication, problem-solving, and analytical skills; knowledge of quality/regulatory standards affecting API, bulk drug, or finished goods manufacturing. Preferred: experience with combination products, regulatory submissions, and design change impact assessments. High-value: focus on combination products including infusion pumps, syringes, and aesthetic devices; lifecycle management; design transfer and change control; support for regulatory interactions and audits. Work setup: not specified.