Senior Quality Engineer

Job Summary We are seeking an experienced Senior Quality Engineer – Medical Devices to lead and support quality engineering activities across medical device product development, design controls, manufacturing technical transfers, and sustaining operations. Roles and Responsibilities Develop, review, and approve quality plans, product specifications, engineering changes, and product development deliverables. Lead and maintain design control activities in accordance with FDA and ISO regulatory requirements. Develop, review, and maintain risk management documentation, including DFMEAs, PFMEAs, and risk management reports, in compliance with ISO 14971. Review and approve Design Verification and Validation (V&V) protocols, reports, and related documentation. Support equipment and manufacturing process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Lead investigations into product nonconformances, process deviations, and quality-related issues. Drive Corrective and Preventive Actions (CAPA) and conduct structured Root Cause Analysis (RCA) using appropriate problem-solving methodologies. Apply statistical techniques for process capability studies, sampling plans, Measurement System Analysis (MSA), and process improvement initiatives. Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and other quality-system documentation. Support internal, external, and regulatory audits, ensuring compliance with FDA and ISO requirements. Support post-market surveillance activities, complaint investigations, and complaint-trend analysis. Collaborate with cross-functional teams to support manufacturing technical transfers, product launches, and sustaining engineering activities. Education & Experience Bachelor's degree in engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related technical discipline. Master's degree in engineering, Biomedical Engineering, or a related field is preferred. Minimum 8+ years of experience in Quality Engineering within the medical device industry. Strong experience supporting Class II and Class III medical device development and manufacturing. Hands-on experience with design controls, risk management, and product development quality activities. #J-18808-Ljbffr Katalyst-Healthcares-