Stryker Corporation

Staff Quality Engineer, Microbiology and Sterilization

Stryker Corporation$95K — $159K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field.
  • Minimum 4 years of experience in microbiology, sterilization, or related quality engineering roles within a regulated industry.
  • Experience working within FDA, ISO, GMP, or other regulated quality system environments.
  • Experience with sterilization technologies such as Ethylene Oxide (EtO), Gamma, or Electron Beam.

Responsibilities

  • Lead sterilization process development, validation, and requalification activities for new and existing products.
  • Serve as the technical subject matter expert for sterilization methods and microbiology programs.
  • Develop, validate, and maintain microbiological test methods including bioburden and endotoxin.
  • Manage sterility assurance and ensure timely requalification activities.
  • Review product and process changes; assess regulatory and quality impacts.
  • Investigate nonconformances and implement compliant remediation plans.
  • Support regulatory inspections and audits while providing technical guidance.

Benefits

  • Work flexibility with an onsite location.
  • Opportunity to lead critical compliance across product lifecycle.
  • Involvement in cross-functional collaboration with R&D, manufacturing, and regulatory teams.
  • Exposure to regulatory environments, enhancing career growth.
Full Job Description
Work Flexibility: Onsite

Staff Quality Engineer, Microbiology and Sterilization

Irvine, CA

Join Stryker's Quality team in a role focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. This position provides technical leadership supporting product development, manufacturing operations, quality systems, and regulatory requirements. The role works closely with cross-functional teams, external laboratories, and suppliers to ensure microbial control strategies, sterilization processes, and testing activities remain compliant with applicable standards and regulations.

What You Will Do
  • Lead sterilization process development, validation, and requalification activities for new and existing products.
  • Serve as the technical subject matter expert for sterilization methods, microbiology programs, and biocompatibility requirements.
  • Develop, validate, and maintain microbiological test methods, including bioburden, endotoxin, and environmental monitoring programs.
  • Manage sterility assurance level maintenance and ensure requalification activities are completed according to established schedules.
  • Review product, process, and packaging changes; assess regulatory and quality impacts; and author technical documentation and risk assessments.
  • Investigate nonconformances, corrective and preventive actions, and audit findings, and implement compliant remediation plans.
  • Maintain cleanroom contamination control validation strategies and oversee environmental monitoring activities.
  • Support regulatory inspections and internal, external, and supplier audits while providing technical guidance to research and development, manufacturing, quality, and regulatory teams.


What You Will Need

Required Qualifications
  • Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field.
  • Minimum 4 years of experience in microbiology, sterilization, or related quality engineering roles within a regulated industry.
  • Experience working within FDA, ISO, GMP, or other regulated quality system environments.
  • Experience with sterilization technologies such as Ethylene Oxide (EtO), Gamma, Electron Beam, or other terminal sterilization methods.

Preferred Qualifications
  • Knowledge of microbiological testing, and biocompatibility evaluation principles.
  • Experience supporting regulatory inspections, supplier audits, and quality system audits.
  • Experience with risk management activities and validation of microbiological or sterilization processes.


  • $95,800 - $159,600 USD Annual


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

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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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