Stryker Corporation

Staff Quality Engineer

Stryker Corporation • $89K — $148K *
Arlington, TN 38002In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, Quality, Life Sciences, Regulatory Affairs, or a related technical discipline.
  • 4+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry; medical device experience preferred.
  • Strong understanding of medical device manufacturing processes, ISO 13485, and GMP requirements.
  • Demonstrated expertise in CAPA, Risk Management, Audits, Validation, and Statistical Methods.
  • Proven ability to lead quality initiatives and drive compliance with technical and regulatory requirements.

Responsibilities

  • Provide quality leadership and oversight for manufacturing processes and product quality.
  • Own investigations, nonconformances (NCs), and corrective and preventive actions (CAPAs).
  • Partner with cross-functional teams to maintain compliance and enhance product performance.
  • Lead and resolve internal and supplier nonconformances (NCs) with effective corrective actions.
  • Analyze quality metrics, identify improvement opportunities, and implement corrective actions.
  • Lead local and global quality initiatives to improve product quality and manufacturing performance.
  • Participate in audits and manage quality relationships with suppliers.

Benefits

  • Comprehensive work environment focused on quality excellence.
  • Opportunities for professional development and continuous improvement training.
  • Involvement in diverse cross-functional projects.
  • Exposure to regulatory agency interactions and compliance assurance.
  • Collaboration within a global organization.
Full Job Description
Work Flexibility: Onsite

Stryker is seeking a Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional business teams. This role is responsible for driving quality excellence through risk management, CAPA ownership, supplier quality oversight, audit participation, and continuous improvement initiatives. The successful candidate will serve as a quality subject matter expert, ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements while influencing business performance through data-driven decision making.

What You Will Do
  • Provide quality leadership and oversight for manufacturing processes and product quality.
  • Own and drive investigations, nonconformances (NCs), corrective and preventive actions (CAPAs), and root cause analysis activities.
  • Partner closely with Operations, Engineering, Supply Chain, and cross-functional business teams to provide quality oversight and direction on product and process performance while ensuring compliance with ISO 13485, GMP, regulatory requirements, and Stryker Quality Systems.
  • Lead investigations and resolution of internal and supplier-driven nonconformances (NCs), driving timely containment, root cause analysis, corrective and preventive actions (CAPAs), and effective closure.
  • Disposition nonconforming products through Material Review Board (MRB) processes, issue nonconformances as appropriate, and support product holds, potential product escapes, and quality risk mitigation activities.
  • Serve as a subject matter expert in risk management, CAPA, change management, concession management, validation, statistical techniques, inspection methods, sampling plans, process capability, and quality system requirements.
  • Develop, assess, and approve quality-related changes, concessions, and risk management activities through data-driven decision making and sound quality engineering principles.
  • Analyze quality metrics and KPI trends, identify opportunities for improvement, and implement corrective actions that drive operational excellence and continuous improvement.
  • Lead and support local and global quality initiatives, utilizing Lean, Six Sigma, Human Error Prevention, and risk-based methodologies to improve product quality and manufacturing performance.
  • Optimize inspection methods, statistical sampling approaches, and process controls to ensure product quality, process capability, and compliance with established standards.
  • Participate in and lead internal, external, customer, supplier, and regulatory audits, including audit preparation, logistics coordination, response development, and engagement with regulatory agencies.
  • Support validation strategies, execution, and approval activities while ensuring compliance with applicable quality and regulatory requirements.
  • Lead or support manufacturing transfers, process changes, and product launches across facilities, ensuring quality objectives and regulatory requirements are maintained.
  • Manage supplier quality relationships through performance monitoring, quality issue resolution, nonconformance management, corrective actions, and continuous improvement initiatives.
  • Coach, mentor, and provide technical leadership to quality professionals and cross-functional teams on quality systems, risk management, CAPA, problem-solving methodologies, and regulatory compliance.
  • Represent Quality on local, global, and corporate review boards, providing expert input, technical guidance, and strategic recommendations that support business objectives and product quality.


What you need
  • Bachelor's degree in engineering, Quality, Life Sciences, Regulatory Affairs, or a related technical discipline.
  • 4+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry; medical device experience preferred.
  • Strong understanding of medical device manufacturing processes, ISO 13485, GMP, and quality system requirements.
  • Demonstrated expertise in quality engineering principles including CAPA, Risk Management, Root Cause Analysis, Audits, Validation, and Statistical Methods.
  • Experience with risk-based methodologies and statistical techniques, including Process Risk Assessments, Statistical Sampling Plans, Process Capability Analysis, and Gauge R&R studies.
  • Strong analytical, problem-solving, critical thinking, and decision-making skills with exceptional attention to detail.
  • Ability to communicate effectively across all levels of the organization and influence cross-functional stakeholders.
  • Proven ability to lead quality initiatives, mentor others, and drive compliance with technical, regulatory, and quality requirements.
  • Self-starter with the ability to manage multiple priorities in a fast-paced, collaborative manufacturing environment.
  • Strong interpersonal, conflict resolution, and relationship-building skills with a customer-focused, stakeholder-oriented approach.


Preferred
  • Medical device industry experience supporting manufacturing operations.
  • Lean Six Sigma certification or formal training.
  • Experience interacting with regulatory authorities such as FDA, TÜV, Notified Bodies, Ministry of Health (MoH), or other regulatory agencies.
  • Experience supporting supplier quality, process validation, inspection optimization, and manufacturing transfers.
  • Demonstrated success applying continuous improvement methodologies and Human Error Prevention principles within manufacturing environments.
  • Experience leading cross-functional quality projects and representing Quality during audits, inspections, and business reviews.
  • Willingness to travel as needed and collaborate within a multi-site global organization.
  • Developing overlays, develop inspection methods, Gages, GD&T understanding, Print reading.


United States of America Pay Ranges:
  • USN: $89,300 - $148,800 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
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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