Stryker Corporation

Senior Staff Quality Engineer

Stryker Corporation$133K — $222K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or related discipline.
  • Minimum 6 years of experience in Quality and/or R&D in the medical device industry.
  • Strong knowledge of ISO 13485, GDP, GMP, and medical device regulations.
  • Experience leading root cause investigations and CAPA activities.
  • Preferred: Master's degree and ASQ Quality Engineer certification.

Responsibilities

  • Collaborate with customers and cross-functional teams to address quality issues.
  • Mentor and oversee nonconformance/CAPA processes and activities.
  • Lead quality initiatives and projects within the division.
  • Act as a recognized process owner with expertise in multiple quality areas.
  • Contribute to local and corporate quality processes and initiatives.
  • Review change management activities for compliance and effectiveness.
  • Analyze KPI trends to inform continuous improvement efforts.

Benefits

  • Hybrid work flexibility
  • Mentorship opportunities
  • Engagement with regulatory representatives
  • Opportunity to lead internal and external audits
  • Contributions to continuous improvement processes.
Full Job Description
Work Flexibility: Hybrid

Stryker is hiring a Senior Staff Quality Engineer for our Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulation and standards.

What you will do
  • Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
  • Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
  • Leads quality initiatives or projects.
  • Recognized process owner, with expertise across multiple quality areas.
  • Provides input into local, global, and corporate processes, represents function on review boards and teams.
  • Review and approval of change management activities, challenges effectiveness and drives strong review.
  • Interpret KPI trends, drive continuous improvement process.
  • Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
  • Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
  • Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
  • Coach and mentor others in quality topics and activities.


Required
  • Bachelor's degree in a science, engineering or related discipline.
  • Minimum 6 years of experience in Quality and/or Research & Development (R&D) within the medical device industry, supporting product development, design controls, risk management, quality systems, and post-market surveillance activities.
  • Strong knowledge of medical device quality and regulatory requirements, including ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), post-market compliance requirements, and U.S. and international medical device regulations.
  • Experience leading and supporting root cause investigations, nonconformance management, CAPA activities, complaint investigations, and post-market quality initiatives to drive continuous improvement and regulatory compliance.

Preferred
  • Masters degree
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
  • Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
  • ASQ Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE) certification preferred.
  • Six Sigma Green Belt or Black Belt certification preferred, with demonstrated application of continuous improvement and process optimization methodologies.


$133,400 - $222,300 USD Annual

Travel Percentage: 10%

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.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Stryker Corporation.

Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
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

Similar Jobs

More Jobs at Stryker Corporation

More Healthcare Jobs

Find similar Senior Staff Quality Engineer jobs: