Quality Engineer
Core
Authoring, reviewing, and approving QMS documents and records to support plant quality objectives while acting as the quality representative on project teams.
Role type
Quality Engineer (Medical Devices)
Builds
Quality documentation, inspection plans, test methods, and quality standards for medical device manufacturing.
Domain
Medical Devices / Manufacturing
Required skills
QMS documentation, validation protocols, root cause analysis, non-conformance management, FDA QSR, ISO13485, statistical software (Minitab, Excel), calibration management, audit participation
Preferred skills
ASQ CQE, ASQ CQA, Six Sigma Green/Black Belt, software qualification, textile experience
Technologies
Minitab, MS Excel
Responsibilities
Lead validation activities including authoring and executing protocols for new product development and process improvements; Design and conduct quality engineering studies to identify root causes of nonconformances; Lead investigations into quality issues, initiate NCRs, and manage disposition of nonconforming materials through MRB processes; Develop and maintain quality documentation including inspection plans and test methods; Review and approve incoming, in-process, and final inspection records; Investigate customer complaints and support corrective and preventive actions; Coordinate calibration activities for measuring and monitoring equipment; Participate in internal and external audits and regulatory inspections.
Seniority
Mid-level, hands-on IC