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This position plays a key role in ensuring product quality and regulatory compliance across the full lifecycle of advanced medical devices. You will collaborate cross-functionally to drive continuous improvement, streamline processes, and uphold the highest standards of excellence in manufacturing and design.
The Quality Manager will lead all quality systems, inspection activities, supplier quality programs, ISO 9001 compliance efforts, and continuous improvement initiatives within a manufacturing environment. This individual will partner closely with Engineering, Manufacturing, and Supply Chain teams to drive product quality, resolve technical issues, develop quality strategy, and lead a high-performing Quality team.
This position leads quality operations within a precision manufacturing setting, ensuring consistent adherence to standards and driving continuous improvement. You will partner cross-functionally to enhance processes, resolve technical challenges, and maintain a robust quality management system.
The Senior Quality Engineer is responsible for leading and maintaining processes across the product lifecycle in compliance with applicable regulatory standards and internal quality requirements. This role ensures that product risks are systematically identified, evaluated, mitigated, and monitored, supporting the development and commercialization of their product line.
My client is seeking a Senior Quality & Regulatory Engineer to serve as the primary U.S.-based quality and regulatory leader for a growing medical device organization. This individual will oversee FDA compliance, supplier quality, post-market activities, and global quality system oversight while partnering closely with international manufacturing operations
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