Stryker Corporation

Staff Quality Engineer

Stryker Corporation$98K — $163K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor of Science in Engineering or related technical discipline
  • Minimum 4 years of quality engineering experience in a regulated industry, preferably medical device manufacturing.
  • Familiarity with quality standards (e.g., ISO 13485, GMP, GDP)
  • Experience in statistical analysis and risk-based methodologies
  • Proficiency with data visualization tools, such as Power BI

Responsibilities

  • Review customer complaints for regulatory reportability, including to the FDA
  • Prepare and submit Medical Device Reports (MDRs) and international vigilance reports
  • Lead post-market product investigation, developing test plans and documenting findings
  • Collaborate with engineering teams to validate design changes based on performance data
  • Act as the quality owner for the Tables Product Line, driving improvements
  • Work with sales teams to gather complaint data for timely investigations
  • Create customer response letters in accordance with findings and regulatory requirements
  • Establish dashboards and reports to convert data into actionable insights
  • Develop post-market surveillance plans and reports for global products
  • Lead risk management and quality system improvement initiatives

Benefits

  • Hybrid work flexibility
  • Opportunities for professional development
  • Engagement with cross-functional teams
  • Ability to influence product quality and compliance
  • Exposure to global regulatory environments
Full Job Description
Work Flexibility: Hybrid

Staff Quality Engineer - Flower Mound, TX

This role sits at the intersection of product quality, regulatory compliance, and data-driven decision making-supporting post-market engineering activities while leading improvements across systems and processes. You will work across teams to ensure product performance, complaint handling, and reporting meet global standards.

What you will do
  • Review customer complaints and determine reportability to regulatory authorities, including FDA and international bodies
  • Support preparation and submission of Medical Device Reports (MDRs) and international vigilance reports in accordance with regulatory timelines
  • Lead investigations into post-market product issues, including developing and executing test plans and documenting results
  • Partner with engineering teams to implement and validate design and engineering changes based on field performance and complaint trends
  • Act as the post-market quality owner for the Tables Product Line, driving improvement across mechanical and electromechanical systems
  • Partner with sales teams and healthcare professionals to gather complete complaint data and drive investigations to timely, high-quality, and actionable outcomes
  • Develop customer response letters aligned to investigation findings and regulatory requirements
  • Build and maintain dashboards and reports using data from systems (e.g., quality databases), translating data into actionable insights
  • Author and review post-market surveillance plans and reports for products distributed globally
  • Lead risk management activities and quality system improvements by identifying gaps, implementing corrective actions, and partnering with cross-functional teams on product and process enhancements


What you will need

Required qualifications:
  • Bachelor of Science in Engineering or related technical discipline
  • Minimum 4 years of experience in Quality Engineering within a regulated industry. Medical device manufacturing is strongly preferred.


Preferred qualifications:
  • Familiarity with quality standards and regulations (e.g., ISO 13485, GMP, GDP)
  • Experience with statistical analysis and risk-based methodologies
  • Experience with data visualization and reporting tools (e.g., Power BI)
  • Experience supporting post-market surveillance or complaint handling processes
  • Experience supporting engineering changes and product investigations
  • Experience working with mechanical or electromechanical systems


US10: $98,200 - $163,700 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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