Stryker Corporation

Senior Quality Assurance Manager - Surgical Support & Post Market

Stryker Corporation$176K — $293K *
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, or related technical field.
  • 10+ years of experience in a regulated manufacturing environment (medical device, pharmaceutical, biomedical, or automotive).
  • 4+ years of people leadership experience, including team development and performance management.
  • Experience in product quality throughout the product lifecycle, including post-market quality.
  • Knowledge of quality and risk management tools (RCA, FMEA, SPC, CAPA, Six Sigma).
  • Familiarity with compliance to Quality Systems and regulatory requirements, particularly FDA standards.
  • Experience leading cross-functional quality initiatives across various functions and products.

Responsibilities

  • Lead Quality Assurance for surgical device portfolios in the Endoscopy business.
  • Define quality strategy and establish performance metrics in partnership with leaders.
  • Provide direction for post-market surveillance and customer-focused quality initiatives.
  • Analyze product quality trends and communicate insights to senior leadership.
  • Oversee resolution of complex quality issues and engineering change assessments.
  • Ensure compliance with global regulatory standards and support audits.
  • Drive improvements in quality system processes and foster operational excellence.
  • Develop and manage high-performing teams toward achieving objectives.

Benefits

  • Work flexibility with hybrid or onsite options.
  • Opportunities for continuous improvement initiatives.
  • Collaboration with cross-functional teams in R&D, Operations, and Regulatory Affairs.
  • Strategic involvement in product lifecycle management.
  • Focus on customer satisfaction and quality excellence.
Full Job Description
Work Flexibility: Hybrid or Onsite

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

Travel Percentage: 20%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

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Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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