Job Summary
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The Quality Engineer Sr will be responsible for ensuring the highest standards of quality throughout our organization and provide strategic thinking with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.
Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management. Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.Lead and support nonconformance handling, deviations, disposition, and approval of nonconforming product. Support site leadership during internal and external audits and inspections; act as a subject matter expert during FDA, notified body, and supplier inspections. Analyze quality metrics and trends; drive continuous improvemen...