Quality Manager (medical​/aerospace machining

Tek Pro is partnered with a high-tech aerospace/medical device contract manufacturer in the Bay Area in their search for a Quality Manager!

• High growth, multi-state manufacturing organization with 50+ years in business
• This individual is responsible for QMS management, personnel management, customer communication, and hands-on inspection leadership.
• Proven experience required in precision machining for medical, aerospace, or other highly regulated manufacturing sectors.

• Manage the company’s Quality Management System and inspection functions
• Maintain compliance with ISO 9001, ISO 13485, and applicable customer requirements
• Coordinate internal, customer, supplier, and external audits
• Lead management review meetings and internal audit activities
• Manage customer complaints, rejects, corrective actions, and quality concerns
• Oversee CAPA, nonconformance, deviation, and change control activities
• Maintain customer quality documentation, certifications, and reporting
• Develop and maintain IQ, OQ, and PQ documentation for applicable equipment and processes
• Support SPC, capability studies, and other quality improvement activities
• Manage and monitor supplier quality performance
• Recruit, train, supervise, and develop Quality Department employees
• Establish department goals, metrics, and performance expectations
• Work closely with Manufacturing, Engineering, Sales, and other departments to resolve quality issues
• Support continuous improvement efforts including 5S, Kaizen, DMAIC, and root-cause analysis
• Ensure departmental safety and OSHA requirements are followed

• 10+ years of progressive manufacturing, operations, or quality experience
• 5+ years of Quality Management experience
• Strong knowledge of ISO 13485 and ISO 9001
• Experience conducting internal, customer, supplier, and external audits
• Experience with CAPA, 5 Why, root-cause analysis, and corrective actions
• Experience with supplier quality management and auditing
• Experience with nonconformance reports, deviations, CAPA, and change requests
• Knowledge of SPC and Minitab
• Strong understanding of manufacturing processes and quality practices
• Strong leadership, communication, organization, and problem-solving skills