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T
Tecomet
Senior Quality Engineer
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Job Description
The Senior Quality Engineer supports manufacturing quality systems and regulatory compliance, resolves quality issues with operations, and drives continuous improvement. Responsibilities include managing audits, investigating customer complaints, preparing quality plans and documentation, coordinating process validations, and applying statistical and Six Sigma methods in a regulated manufacturing environment. Responsibilities Maintain applicable quality systems, environmental requirements, and FDA certifications. Facilitate operator-owned quality programs and support MRB and RMA processes. Partner with manufacturing and operations to resolve quality, cost, and schedule issues. Prepare FMEAs, control plans, quality plans, and PPAP documentation; coordinate process validations. Investigate customer complaints and manage related CAPA, deviations, and responses. Generate quality metric reports, participate in audits and inspections, and maintain quality procedures. Required Skills Quality management systems FDA regulations