Stryker Corporation

Staff Quality Compliance Engineer

Stryker Corporation$102K — $171K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or related discipline
  • Minimum 4 years of experience in regulatory compliance, quality, engineering, or a related function
  • Experience in the medical device or healthcare industry
  • Proficient in regulatory impact assessments and standards gap analyses
  • Familiarity with design controls, risk management, and quality management systems
  • Knowledge of global medical device regulations and international standards

Responsibilities

  • Lead the Standards & Regulations Management Compliance program as the Division Process Owner
  • Monitor and identify new or revised global regulatory requirements and standards
  • Interpret regulatory requirements and provide guidance to cross-functional teams
  • Conduct gap assessments comparing regulations and existing processes
  • Evaluate regulatory changes' impact on products and quality management systems
  • Develop and implement compliance action plans for conformity
  • Support internal and external audits as a subject matter expert

Benefits

  • Work flexibility with an onsite requirement
  • Opportunity to influence global regulatory compliance efforts
  • Collaboration with cross-functional teams will enhance professional growth
  • Direct involvement in assessments and audits offers a robust career development path
  • Exposure to evolving international standards and regulations adds unique experience
Full Job Description
Work Flexibility: Onsite

Staff Quality Compliance Engineer

Irvine, CA

Join Stryker in a key role supporting global regulatory compliance across the product lifecycle. This position provides technical leadership for standards and regulations management, ensuring medical device products and quality systems remain aligned with evolving global regulatory requirements. The role partners closely with cross-functional teams to assess regulatory changes, evaluate impact, and implement compliance actions across products and processes.

What You Will Do
  • Lead the Standards & Regulations Management Compliance program as the Division Process Owner, aligning processes and compliance activities across divisions.
  • Monitor and identify new or revised global regulatory requirements, standards, and guidance applicable to medical devices and quality systems.
  • Interpret regulatory requirements and standards and provide guidance to teams responsible for product development, sustaining engineering, and quality management.
  • Conduct gap assessments comparing new or updated regulations and standards to existing requirements and processes.
  • Evaluate the impact of regulatory and standards changes on commercialized products and quality management system processes.
  • Develop and implement compliance action plans to maintain product and quality system conformity.
  • Partner with cross-functional teams to execute compliance activities and ensure required documentation is completed according to company procedures.
  • Support internal and external audits as a subject matter expert and review technical documentation, test protocols, and reports for regulatory conformity.


What You Will Need

Required Qualifications
  • Bachelor's degree in Engineering, or related discipline.
  • Minimum 4 years of experience in regulatory compliance, quality, engineering, or a related function.
  • Experience working within the medical device, healthcare, or regulated industry.
  • Experience performing regulatory impact assessments and standards gap analyses.
  • Experience with design controls, risk management, and quality management systems.
  • Knowledge of global medical device regulations and international standards.

Preferred Qualifications
  • Experience supporting internal and external regulatory or quality audits.


  • $102,700 - $171,100 USD Annual


Travel Percentage: None

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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