Stryker Corporation

Senior Quality Engineer

Stryker Corporation • $89K — $148K *
Irvine, CA 92620In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a science, engineering or related discipline.
  • Minimum of 2 years of quality engineering experience with knowledge of quality system principles.
  • Experience applying risk management principles and conducting compliance risk assessments in a regulated environment.
  • Proficiency with Microsoft Office for data analysis and reporting.
  • Experience in developing and executing test method validations and conducting measurement system analyses.

Responsibilities

  • Partner with operations and suppliers to drive product quality performance and resolve issues.
  • Own and support nonconformance investigations, corrective actions, and closure processes.
  • Collaborate with suppliers on quality concerns and manage supplier corrective actions.
  • Monitor and report quality metrics, applying statistical methods to identify improvements.
  • Support manufacturing complaints and regulatory compliance activities.
  • Develop and improve quality system documentation and inspection methods.
  • Participate in audits and provide expertise to ensure compliance with requirements.

Benefits

  • Onsite work flexibility.
  • Opportunity to lead quality improvement initiatives.
  • Exposure to cross-functional collaboration and supplier management.
  • Engagement with regulatory compliance activities and audits.
Full Job Description
Work Flexibility: Onsite

Senior Quality Engineer for our Peripheral Vascular division in Irvine, CA to provide Quality Engineering support for quality assurance, quality control, and continuous improvement activities across manufacturing operations, products, and processes. Partner closely with cross-functional teams and suppliers to resolve quality issues, drive corrective and preventive actions, and enhance overall quality performance. Lead and support initiatives that improve product quality, operational efficiency, and customer satisfaction while ensuring compliance with applicable regulatory requirements, industry standards, and quality system expectations.

What you will do
  • Partner with Operations, suppliers, and cross-functional teams to drive product and process quality performance, resolve quality issues, and support continuous improvement initiatives.
  • Own and support nonconformances (NCs), CAPAs, MRB activities, and product disposition, ensuring timely investigation, root cause analysis, corrective actions, and closure within quality systems.
  • Collaborate with suppliers to address quality concerns, manage supplier corrective actions, evaluate supplier changes, perform PPAP activities, and support supplier part certification programs.
  • Monitor, analyze, and report quality and process performance metrics, applying statistical methods, process controls, and risk management principles to identify trends and drive improvements.
  • Support manufacturing-related complaints, field actions, commercial holds, and containment activities to ensure product quality and regulatory compliance.
  • Develop, review, and improve quality system documentation, procedures, inspection methods, sampling plans, and Human Factors practices that enhance product and process effectiveness.
  • Support process, equipment, and supplier validations/qualifications, measurement system analysis (MSA), engineering changes, supplier-initiated changes, and manufacturing transfer activities.
  • Participate in internal and external audits and provide quality subject matter expertise to ensure compliance with applicable quality system and regulatory requirements.


What you need:

Required
  • Bachelors degree in a science, engineering or related discipline
  • Minimum of 2 years of quality engineering experience with demonstrated knowledge of quality system principles, including risk management, CAPA, auditing, and statistical methodologies.
  • Experience applying risk management principles and conducting compliance risk assessments within a regulated environment.
  • Demonstrated proficiency using Microsoft Office tools to analyze data, create reports, and support cross-functional business activities.
  • Experience developing and executing test method validations, including authoring and revising protocols, reports, procedures, and/or work instructions, as well as conducting measurement system analyses (e.g., Gage R&R).
  • Experience managing supplier quality activities, including supplier qualification, performance monitoring, and quality issue resolution.

Preferred
  • CQE, or CRE and Six Sigma Green or Black belt preferred Or related
  • Experience in the medical device industry with knowledge of U.S. and international medical device regulations, including familiarity with ISO 13485, 21 CFR Part 820, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
  • Experience with regulatory inspections and audits, including direct interaction with regulatory agencies such as FDA, TUV, MoH, etc.
  • Experience developing, programming, and validating automated inspection programs, protocols, and recipes for manufacturing or quality inspection systems.


$89,400 - $148,900 USD Annual

Travel Percentage: 0%

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
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Stryker Corporation

More Healthcare Jobs

Find similar Senior Quality Engineer jobs:

NationwideIrvine, CA