Microbiologist

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 our RA/QA team, that's exactly what you'll do! At Stryker, we provide our Regulatory Affairs teams the opportunity to learn new things, as well as growth opportunities. If you're in working at one of the World's Best Workplaces, apply today!
Who we want:
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Stryker is hiring a Microbiologist in Arlington, TN.
What you will do:
- Ensure accurate, reproducible, and timely QC testing in support of manufacturing; support development and validation studies on an as-needed basis
- Perform testing on in-process product, final product, and raw materials for routine testing and validation testing; communicate results through appropriate documentation and batch records, statistical analysis and trending; acquire and maintain cleanroom and gowning qualification; perform instrument maintenance; identify and report equipment and method failures; identify areas for continuous improvement
- Performs all aspects of the monitoring program with a working knowledge of company specifications and government regulations that govern the program
- Ensures that all testing is performed according to appropriate standards
- Performs necessary testing and analyzes data
- Reports findings in a clear and concise manner conforming to company format
- Trends data to ensure continued compliance
- Provides support to the manufacturing operation in areas related to quality from a microbiological standpoint.
- Reviews data and assigns disposition to several testing procedures including but not limited to sterility, bioburden, environmental data, validations, etc.
- Advise on microorganisms as they relate to the cleaning, disinfection and sterilization of reusable medical devices
- Advise on microorganisms as they relate to the terminal sterilization of single use medical devices
- Work closely with R&D teams to develop new products and lead continuous quality improvement initiatives
- Apply ISO, FDA and other applicable guidelines to the biological analysis of medical devices
- Actively support and advise on new product development activities with minimal support
- Lead and participate in the development and improvement of processes for existing and new products with minimal support
- Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ) for terminally sterilized products
- Review nonconforming material and system documentation
- Support and advise regulatory teams on the review and writing of 510(k) submissions
- Participate in internal regulatory audits (FDA, notified body) as needed
- Maintain and improve internal SOP's / Work Instructions with respects to newly evolving and changing standards and regulatory environment
What you will need:
Basic Qualifications:
- Bachelor's Degree in Microbiology or a related discipline (Genetics, Cell Biology, Biology, etc.)
Preferred Qualifications:
- 2+ years of experience in microbiology laboratory testing, cleanroom monitoring, and/or sterilization process monitoring
- Laboratory equipment maintenance and validation experience
- Experience in medical device, biologics and/or pharmaceutical industries
- Excellent verbal and written communication skills
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. (https://careers.stryker.com/referrals/)