Stryker Corporation

Staff Engineer, Quality

Stryker Corporation • $107K — $178K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
  • 4+ years of experience in Quality Engineering or Quality Assurance in regulated environments.
  • Experience in a regulated manufacturing setting is essential.
  • Preferred experience in medical device manufacturing.
  • Familiarity with ISO 13485, GMP, and statistical quality methods.

Responsibilities

  • Support manufacturing readiness and product transition activities.
  • Identify and implement process improvements for product quality and efficiency.
  • Lead investigations of nonconformances and ensure resolution.
  • Own and manage Corrective and Preventive Actions (CAPAs).
  • Review and disposition nonconforming products via Material Review Board activities.
  • Collaborate with teams to resolve quality issues and sustain compliance.
  • Evaluate quality performance metrics and drive continuous improvement initiatives.

Benefits

  • Opportunity to support a newly integrated business preparing for commercial launch.
  • Engage with cross-functional teams, enhancing collaborative skills.
  • Contribution to quality metrics and process improvements that impact long-term performance.
Full Job Description
Work Flexibility: Onsite

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Quality Engineer. In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross-functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations.


This role offers a unique opportunity to support a newly integrated business preparing for commercial launch. As the site's primary Quality Engineer, you will play a key role in helping to establish quality metrics, drive process improvements, support manufacturing readiness activities, and enhance long-term quality and operational performance.


What You Will Do

  • Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.
  • Identify and implement process improvements that enhance product quality, manufacturing efficiency, inspection effectiveness, and compliance.
  • Lead investigations of internal and supplier nonconformances, ensuring timely resolution and closure.
  • Own Corrective and Preventive Actions (CAPAs), using root cause analysis to identify issues and implement sustainable solutions.
  • Review and disposition nonconforming product through Material Review Board activities and containment actions.
  • Partner with operations and cross-functional teams to resolve quality issues and maintain process compliance.
  • Evaluate manufacturing and quality performance metrics, identify trends, and drive continuous improvement initiatives.
  • Support manufacturing complaints, product field actions, and quality-related investigations.
  • Review and approve change management activities, challenge effectiveness, and verify implementation of quality controls.
  • Support process validation, equipment qualification, measurement system analysis, audits, and supplier quality performance activities.

What You Will Need

Required Qualifications

  • Minimum bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
  • Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related quality-focused role supporting manufacturing operations within a regulated environment.
  • Experience working within a regulated manufacturing environment.

Preferred Qualifications

  • Experience in medical device manufacturing.
  • Training or certification in Lean, Lean Six Sigma, or continuous improvement methodologies.
  • Experience with process capability analysis, statistical sampling plans, and gauge repeatability and reproducibility (Gage R&R) studies.
  • Working knowledge of ISO 13485, Good Manufacturing Practices (GMP), CAPA, risk management, audits, and statistical quality methods

  

 

US20: $107,200 - $178,600 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.


  

 

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.

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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

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