Senior Quality Assurance Manager - Surgical Support & Post Market

Stryker; 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 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.

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