Quality Engineer III
Core
Leads Workcell Quality Operations or NPI teams to implement quality plans, analyze discrepancies, and ensure product quality meets regulatory and customer requirements.
Role type
Senior Quality Engineer (Manufacturing/Validation)
Builds
Quality control plans, validation protocols, and inspection/testing processes for manufacturing.
Domain
Manufacturing / Medical Devices / Regulated Industries
Required skills
Quality control statistics, Lean manufacturing, Data analysis, Validation (ISO 13485/9001), CAPA management, Statistical analysis (Minitab), Team leadership, Process improvement
Preferred skills
ASQ CQE certification, FDA audit experience, Reliability engineering, R&D quality
Technologies
Minitab, Microsoft Office, Quality System software
Responsibilities
Lead development of quality evaluation and control plans; Conduct quality assurance tests and statistical analysis; Manage validation activities and batch record documentation; Recruit and supervise inspectors and technicians; Audit quality systems for compliance; Implement corrective and preventive actions (CAPA).
Seniority
Senior, hands-on IC with team leadership
