Microbiology & Sterility Assurance Expert

Reposted 9 Hours Ago
Be an Early Applicant
3 Locations
In-Office
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Senior Staff Microbiologist will oversee sterilization strategies, lead microbiological processes, ensure regulatory compliance, and mentor teams while collaborating globally.
Summary Generated by Built In
Work Flexibility: Hybrid

Microbiology & Sterility Assurance Expert

Are you ready to make a real impact in a global leader dedicated to delivering safe, high-quality medical devices? We’re seeking a top-tier Microbiology & Sterility Assurance Expert to play a critical role in shaping our microbiological and sterilization strategies ensuring the safety and compliance of our products worldwide.

If you’re a driven, innovative influencer with a proven track record in microbiology, from pharma or medical devices, and fluent in English and French, we want to hear from you!

What you will do:

  • Define and execute the GQO T&E global strategy to guarantee safe, high-quality sterilized products while ensuring full regulatory compliance.
  • Lead critical processes such as cleaning, sterilization, environmental monitoring, and product testing.
  • Coach, mentor, and elevate awareness across functions on Micro & Sterility best practices.
  • Serve as the subject matter expert on regulatory standards (FDA, ISO, MDSAP, etc.) and local procedures.
  • Analyze sampling and monitoring data using advanced statistical techniques to identify trends and control points.
  • Review and approve qualification, validation, testing reports, and process improvements.
  • Drive proactive communication to resolve product issues swiftly, minimizing supply chain disruptions.
  • Collaborate seamlessly across global teams, supporting product transfers and the introduction of new innovations.
  • Continuously identify opportunities to enhance efficiency, quality, and margins.

What you need:

Required:

  • Bachelor’s or Master’s in Microbiology or a related field.
  • 6+ years of relevant experience, including at least 2 years in microbiology.
  • Hands-on experience working with regulatory agencies (FDA, MoH, TUV, etc.) and a deep understanding of US and international Microbiology standards for medical devices or pharma.
  • Exceptional communicator with outstanding negotiation and influencing skills.
  • Proven ability to manage multiple projects independently within a complex, matrix organization.
  • Creative thinker, adept at problem-solving, data analysis, and making data-driven decisions.
  • Fluent in English, proficiency in French. German is a plus.
  • Strong interpersonal skills, excellent collaborator, and influential network builder.
  • Knowledge of ISO 11137 (Radiation).

Preferred:

  • Knowledge of: ISO 11737 (Microbiological methods), ISO 19227 (Cleanliness of orthopedic implants), ISO 14644 (Cleanroom).

What we offer:

  • Flat hierarchies and responsibility. Through flat hierarchies, we strengthen the initiative and willingness of our employees to take over responsible tasks.
  • We grow talent. At Stryker we offer great personal and internal career development for our employees, with the possibility to make both vertical and lateral position movement.
  • Team spirit & engagement. We create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.
  • Competitive salary and Benefits. With us, you will receive a competitive salary and benefits commensurate with your job.
  • Recognition of your performance. At our company, outstanding individual and cross-functional team performance is rewarded. Ideas, projects, or other exceptional achievements can be submitted for various awards on a local and global level.
  • Employee Resource Groups (ERGs). Our ERGs are dedicated to fostering an inclusive, diverse, and supportive workplace environment. They provide opportunities for development, networking, and collaboration, and are open to all employees. Our ERGs are committed to promoting inclusion and belonging, helping every individual thrive and contribute to our shared success.

Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

Travel Percentage: 10%

Top Skills

Fda
Iso
Mdsap
Microbiology Standards
Statistical Techniques
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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