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We are seeking a dedicated Clinical Affairs Specialist to join our team in Irvine. The ideal candidate will play a key role in ensuring compliance with clinical regulatory requirements and supporting product development in the medical device manufacturing industry.
The Supplier Quality Engineer role focuses on ensuring supplier compliance and driving quality improvements across the supply chain by conducting audits, managing corrective actions, and supporting new product development. It requires collaboration with internal teams and suppliers to maintain standards, reduce risks, and implement continuous improvement initiatives.
The position leads design assurance activities for new product development, ensuring full compliance with FDA, ISO, and global medical device regulations. It drives quality engineering efforts across the product lifecycle, including risk management, verification/validation, and process validation, while supporting cross‑functional teams and suppliers.
This is a high-level Quality Engineering role with a medical device manufacturer located near the Illinois-Wisconsin border. The position is responsible for overseeing all QA/QC activities within a metal fabrication environment.
Lead and oversee quality engineering activities across manufacturing operations. Develop, implement, and maintain quality management systems in compliance with ISO/TS 16949 standards.
The Lead Quality Engineer will play a critical role in ensuring the organization maintains its reputation for excellence in precision manufacturing. This position will lead quality initiatives across production, drive continuous improvement, and ensure compliance with ISO/TS 16949 and customer-specific requirements.
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