Strategic Quality Operations Leader - Medical Devices

Senior Manager Quality Operation(Medical Devices)The OpportunityA global, innovation-driven medical technology organization is seeking an experienced Senior Manager Quality Operation (Site Quality Leader) to oversee Quality operations at a high-profile manufacturing facility in Southern California. This role is a key member of the Site Leadership Team and offers the opportunity to shape quality strategy, strengthen compliance, and elevate quality culture across the organization.

This position is ideal for a senior Quality professional who thrives in regulated environments and enjoys leading teams, influencing stakeholders, and driving continuous improvement from product development through post-market performance.Your ImpactIn this highly visible leadership role, you will:

• Serve as the Quality Management Representative for the manufacturing site, providing strategic and technical leadership across end-to-end product and process quality for regulated medical devices
• Lead and develop a team of Quality Engineers and supervisors, with accountability for performance management, goal setting, and talent development
• Drive effective interpretation of quality and performance data to resolve nonconformances, meet customer and regulatory requirements, and support business objectives
• Proactively identify and lead quality improvement initiatives to enhance product capability, process robustness, and operational efficiency
• Ensure ongoing compliance with applicable global quality regulations and standards, including U.S. and international medical device requirements
• Provide guidance to cross-functional teams on quality strategy, risk management, process validation, and continuous improvement initiatives
• Act as an influential peer leader on the Site Leadership Team, strengthening compliance, quality culture, predictive quality practices, and data-driven decision-making

• Bachelor’s degree or higher
• Minimum 10 years of experience in a Quality function within Medical Devices, Pharmaceuticals, or Combination Products
• At least 3 years of people management experience, demonstrating effective leadership, compliance excellence, and risk mitigation

• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), and/or Six Sigma Black Belt
• Demonstrated experience with:
  • Regulatory authority interactions and audits
  • Quality engineering, process validation, and nonconforming material control
  • Risk management, field actions, recalls, and post-market surveillance
  • Continuous process and product improvement initiatives
• Proven ability to influence across functions and levels, including executive leadership
• Strong written and verbal communication skills, with the ability to present clear, fact-based insights
• Decisive, results-oriented leadership style with strong problem-solving and prioritization skills