Senior Quality Assurance Manager - Surgical Support & Post Market

Stryker is hiring an Senior Quality Assurance Manager - Surgical Support & Post Market in San Jose, CA supporting our Endoscopy division, who will provide strategic leadership for quality activities across the Endoscopy business, supporting both product lifecycle management and post-market quality performance. This role is responsible for driving quality excellence, regulatory compliance, customer-focused outcomes, and continuous improvement initiatives while partnering closely with cross-functional leaders across R&D, Operations, Regulatory Affairs, and Commercial teams. The Senior Manager will lead a high-performing team, leverage quality and reliability data to influence business decisions, and ensure the effective execution of quality strategies that support product performance, patient safety, and organizational objectives.

Workplace Flexibility: This is a hybrid role requiring the candidate to be within commuting distance to San Jose, CA. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to the facility as needed.

What you will do:

• Lead Quality Assurance support for legacy surgical device portfolios, overseeing new product development, post-market quality, and lifecycle management across the Endoscopy business.
• Partner with cross-functional leaders to define quality strategy, establish key performance metrics, and drive continuous improvement initiatives that enhance product quality, reliability, and customer satisfaction.
• Provide strategic direction for post-market surveillance and customer-focused quality initiatives, leveraging data-driven insights to influence business decisions and risk mitigation activities.
• Monitor, analyze, and communicate product quality and reliability trends to senior leadership, driving proactive actions and executive-level reviews to ensure sustained product performance.
• Lead resolution of complex quality issues by chairing cross-functional review boards, overseeing engineering change assessments, and ensuring robust risk analysis and verification activities.
• Ensure compliance with global regulatory and quality system requirements, including FDA and international standards, while supporting regulatory inspections and external audits.
• Evaluate and improve quality system processes, driving corrective and preventive actions and fostering a culture of operational excellence and continuous improvement.
• Build, lead, and develop high-performing teams through talent acquisition, coaching, performance management, workforce planning, and accountability for achieving organizational objectives.

What you need

Required

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum of 10+ of experience in a regulated manufacturing environment (medical device, pharmaceutical, biomedical, or automotive),
• Minimum of 4+ years of people leadership experience, including team development, performance management, and talent acquisition.
• Experience supporting product quality throughout the product lifecycle, including post-market quality, customer quality, quality engineering, and/or manufacturing quality.
• Demonstrated application of quality and risk management tools, including Root Cause Analysis, FMEA, Statistical Process Control (SPC), CAPA, and/or Six Sigma methodologies.
• Experience supporting compliance with Quality Systems and regulatory requirements, including FDA regulations, audits, inspections, and/or international quality standards.
• Experience leading cross-functional quality initiatives, process improvements, or quality system enhancements across multiple functions, products, or sites.

Preferred

• Advanced degree (MBA, MS, or equivalent) and/or ASQ Quality Engineer certification preferred.

$176,300 - $293,700 USD Annual