Site Quality Leader

Site Quality Leader (Medical Devices) The Opportunity A global, innovation-driven medical technology organization is seeking an experienced 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 Impact 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 Required Qualifications 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 Preferred Qualifications 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 #J-18808-Ljbffr