Quality Engineer III

About the role

The Quality Engineer III leads the Workcell Quality Operations or NPI team, overseeing technicians and inspectors. This role ensures product quality meets company, customer and regulatory standards through quality plans, statistical analysis and lean manufacturing concepts.

Key responsibilities

• Develop, modify and maintain quality evaluation and control plans for material processing and finished products.
• Own the creation and execution of inspection, testing and validation methods, including batch record approval.
• Lead investigations of quality discrepancies, define corrective actions and manage CAPA processes.
• Collaborate with manufacturing, engineering, customers, vendors and subcontractors to ensure requirements are met.
• Audit quality systems, manage statistical process control (SPC) requirements and support ISO 13485, ISO 9001 and CFR 21 Part 820 compliance.
• Recruit, interview and supervise inspectors and technicians, conduct performance evaluations and foster a positive team culture.

Required profile

• BS degree (or equivalent) with at least 5 years of relevant experience, or Master/MBA with at least 4 years.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint) and general computer skills.
• Certified Quality Engineer (ASQ CQE) preferred.
• Strong knowledge of regulated quality systems (ISO 13485, ISO 9001) and FDA/medical device regulations.
• Advanced oral and written English communication skills.

Required skills

• Microsoft Office suite (Excel, Word, PowerPoint).
• Statistical analysis and SPC.
• Quality control statistics and lean manufacturing concepts.
• Validation and verification processes.
• CAPA management and audit procedures.