Job Description

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 SOPs / Work Instructions with respects to newly evolving and changing standards and regulatory environment

What you will need:

Basic Qualifications:

* Bachelors 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