Senior QA Leader - Endoscopy Post-Market & R&D Support

Stryker Group; San Jose (CA); On-site; USD 176,000 - 294,000; Full time

Job summary

Stryker is hiring a Senior Quality Assurance Manager - Surgical Support & Post Market for San Jose, CA, leading quality across the Endoscopy division. You will drive strategies for product quality, lifecycle management, and post-market performance while partnering with R&D, Regulatory Affairs, and Operations.

You will oversee post-market surveillance, risk management, and CAPA processes, ensuring FDA and international standards compliance and a culture of continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 10+ years 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 RCA, FMEA, SPC, CAPA, and/or Six Sigma.
• 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.

Responsibilities

• 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.

Skills

People leadership

Cross-functional collaboration

Data-driven decisions

Regulatory compliance

Quality strategy

Quality metrics

Post-market quality

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Tools

Root Cause Analysis

FMEA

Statistical Process Control

CAPA

Six Sigma

Job description

Stryker is hiring a Senior Quality Assurance Manager - Surgical Support & Post Market for San Jose, CA, leading quality across the Endoscopy division. You will drive strategies for product quality, lifecycle management, and post-market performance while partnering with R&D, Regulatory Affairs, and Operations.

You will oversee post-market surveillance, risk management, and CAPA processes, ensuring FDA and international standards compliance and a culture of continuous improvement.