Posted Jun 01, 2022 Portage, Michigan

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Expires Jul 01, 2022


Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team:

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.



Who We Want

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

Perform testing while providing biological or chemical subject matter expertise to various areas of the business involving cleaning, disinfection, sterility or analytical chemistry.

  • Bioanalytical: Provide subject matter expertise for multiple reprocessing tests, such as reusable device cleaning, disinfection,  sterilization confirmation and have a working knowledge of the associated test methodologies (i.e. Biological Indicator Evaluations, BCA Protein Assay, Total Organic Carbon Analysis, Carbohydrate Assay, Hemoglobin Assay etc.)
  • Analytical chemistry: Provide subject matter expertise for elemental and molecular analysis (i.e. alloys and plastics), residual analysis, material identification & quantification, and a working knowledge of suitable test methodologies (i.e. FTIR, XRF, SEM-EDS, GC/MS, etc.)
  •  Support evaluation, procurement, installation of equipment or procedures under the corporate guidelines
  • Evaluate and test the physical, chemical and/or biological properties of materials for Stryker products
  • Support projects and collaborate with groups such as R&D, Service, Operations, Sales and Marketing
  • Knowledge of methods to test for; chemical or biological identification, residual analysis, corrosion, etc.
  •  Familiarity with international standards, references related to USP, ASTM, AAMI, ISO etc.
  •  Support the development or revision of quality system documents and quality improvement initiatives.
  • Networks with internal and external SME’s in own area of expertise
  • Provide swift and accurate results to internal and external customers
  • Knowledge of product offering, intended use and off label use
  • General knowledge of manufacturing processes applicable to divisional product offering
  • Preparation of glassware, media, reagents and testing supplies.
  •  Careful execution of test protocols.
  •  Safe handling of hazardous biological and chemical reagents.
  •  Perform and document routine checks.
  •  Provide informational support during investigations.
  •  Analyzing and reporting test results.
  •  Documentation following 21 CFR Part 11 (Good Documentation Practices).

What you need

  • Bachelor’s degree in Biology, Chemistry or related discipline is required
  • 3+ years of laboratory experience, analytical testing preferred.
  • 2+ years of experience in medical device product development and or testing
  • Bioanalytical: Cleaning and sterilization procedures, microbial testing and various biological assays
  • Analytical chemistry: GC/MS, FTIR, XRF, SEM-EDS
  • Knowledge of FDA, GMP, ISO, AAMI, NIST, and other medical device regulatory requirements and standards
  • Demonstrated leadership and interpersonal skills with ability to effectively communicate
  • Strong time management skills, ability to manage multiple priorities, and delegate work as needed
  • Ability to accept and manage project risk to drive concurrent projects forward
  • Demonstrated ability to identify opportunities for growth and devise plans for execution
  •  Must be able to review printed and handwritten materials.
  • Ability to interface effectively with health care professionals and medical device customers
  • Must be internally motivated to work independently but capable of collaboration and participation in teams
  • Strong time management skills, ability to manage multiple priorities, and delegate work as needed
  • Demonstrated track record as an independent researcher working in the field of microbiology, analytical chemistry, and/or biochemistry
  • MS in Biology, Chemistry or related discipline is preferred

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

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting