Quality Assurance Manager

The Quality Manager is responsible for overseeing the Quality Assurance function for a manufacturing organization producing precision components for medical devices. This role ensures compliance with AS9100, ISO 9001, and applicable regulatory requirements while driving continuous improvement initiatives to maintain product integrity and customer satisfaction. The Quality Manager partners closely with Materials, Engineering, Production, and Quality teams to ensure accuracy and effectiveness of quality programs.

• Maintain and continuously improve the Quality Management System (QMS) to ensure compliance with AS9100, ISO 9001, and applicable regulatory requirements
• Lead internal, supplier, and external audits (registrars and regulatory bodies)
• Ensure proper document control, record retention, and configuration management
• Oversee CAPA, NCRs, root cause analysis, risk management, and traceability requirements
• Manage incoming, in-process, and final inspections; approve quality plans and validation protocols
• Ensure calibration and maintenance of inspection and measuring equipment
• Lead, mentor, and develop quality engineers, inspectors, and technicians
• Implement Lean, Six Sigma, and continuous improvement initiatives to reduce defects
• Establish quality metrics, dashboards, and performance trend reporting
• Manage customer complaints and ensure timely corrective actions

• Bachelor’s degree in Engineering, Quality Management, or related field
• 4–10 years of quality leadership experience in a manufacturing environment
• Strong knowledge of AS9100, ISO 9001, and FDA requirements
• Experience with audits, CAPA, risk management, and process validation
• Familiarity with ERP and QMS software systems
• Lean manufacturing and Six Sigma experience required

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.