Senior Quality Engineer

The Senior Quality Engineer will serve as the primary Quality Engineering representative, leading cross-functional initiatives to ensure that all design, development, and production activities are in strategic alignment with regulatory and business objectives. Key Responsibilities Quality Leadership : Act as the lead Quality Engineering representative on multi-functional teams for both new product development and sustaining engineering projects, ensuring compliance from concept to commercialization. Regulatory Compliance : Partner with cross-functional teams to ensure that all production processes and product outputs meet stringent regulatory requirements, including but not limited to FDA 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products - HCT/Ps), ISO 13485 (Quality Management System), and ISO 14971 (Risk Management). Risk Management : Play a critical role in the development, maintenance, and execution of risk management activities throughout the product lifecycle, ensuring product safety and efficacy. Design Control : Lead and actively participate in design control activities, focusing on the quality elements of design inputs, outputs, reviews, and transfer. Verification & Validation (V&V) : Drive and support design verification and validation (V&V) efforts, including the development of robust protocols and reports to demonstrate product safety and effectiveness. Process Quality : Lead efforts related to production process validation (IQ, OQ, PQ) and ensure ongoing process control and monitoring. Required Qualifications Bachelor’s degree in Engineering or a related scientific field. Must have experience in Quality Engineering within the medical device, biologics, or tissue combination product industry. In-depth, working knowledge of applicable regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part 1271, ISO 13485, and ISO 14971. Proven experience leading Design Control, Risk Management, and V&V activities for complex products. We are an equal opportunities employer and welcome applications from all qualified candidates.

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