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The Senior Quality Engineer will be responsible for supporting new product development in a regulated environment, with responsibility for design controls, risk management, quality systems, and regulatory compliance. Partners with engineering teams to ensure products are developed, validated, and commercialized in accordance with FDA, ISO, and global quality standards in Mount Laurel, NJ.
The Quality Engineer will drive product reliability and process improvements by identifying root causes of failures and implementing corrective actions. This role is highly hands-on, working across production, engineering, and supply chain to improve quality performance.
The Quality Engineer supports cross-functional teams in identifying, investigating, and resolving product and process quality issues while driving continuous improvement across manufacturing operations. This role is responsible for implementing quality planning tools, analyzing data to reduce risk and cost of poor quality, and ensuring compliance through effective corrective actions, supplier quality support, and new product introduction activities.
Our client is looking for a Quality Assurance Engineer to ensure their medical devices consistently meet quality, performance, and regulatory standards across both design and manufacturing stages. This role includes responsibility for maintaining quality systems, conducting testing and audits, managing CAPA processes, and working closely with engineering and manufacturing teams.
Our client is seeking a Quality Assurance Engineer to ensure their medical devices meet quality, performance, and regulatory requirements throughout design and manufacturing. The role involves quality systems, testing, audits, CAPA management, and collaboration with engineering and manufacturing teams
This is a highly autonomous Quality Engineer role where you'll lead US regulatory and quality oversight for FDA‑cleared implantable medical devices manufactured overseas. You'll act as the primary FDA liaison while building and maintaining a compliant, inspection‑ready quality system across international partners.
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