Senior Microbiologist Reports To
Senior Manager, Quality Sciences Position SummaryThe Senior Microbiologist will be primarily responsible for the biocompatibility, microbiological, and sterility compliance of Stryker's products in accordance with relevant regulatory requirements and standards for medical devices. The microbiologist will oversee and ensure sustained levels of compliance through scientific evaluations, testing, monitoring, and validation of materials, manufacturing, and sterilisation processes.
This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. The job requires attention to detail in making evaluative judgments based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years of experience.
Position RequirementsThe Sr. Microbiologist will be responsible for the Biosafety (Biocompatibility, Sterilisation, and Microbiology) activities and will be a subject matter expert for the Division and manufacturing. This role will coordinate biosafety activities and ensure processes are compliant with standards and regulations and will execute quality initiatives that support compliance to standards as well as identifying opportunities for improving the biosafety processes at the Divisional and manufacturing level. The Sr. Microbiologist will be responsible for the following when applicable (not an exclusive list):
Perform microbiology, sterilization, biocompatibility, and chemical assessments and evaluations for new product introduction, design changes, and process changes/improvements.Coordination of samples for chemical, biocompatibility, microbiological, and sterility testing or assessment.Strong interactions, maintenance, and support of biocompatibility, microbiological, and sterility vendors.Interact with Supplier quality team with respect to vendor biocompatibility, microbiological, and sterility topics.Interpreting data, applying statistical and analysis techniques where applicable, to determine control and trending.Leads NC and CAPA generation and resolution within the Quality Sciences group and across related business units. Strong competency in troubleshooting, correction of NC, and root cause analysis.Performs sterilisation validations and re-qualifications in line with relevant standards and regulations.Mentors and trains team and cross-functional groups as required (induction, GMP, etc.)Subject matter expert to internal & external regulatory requirements (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD/MDR, and individual country regulatory requirements).Subject matter expert to divisional and local procedures, contributing to the development, maintenance, and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.Ensures biocompatibility of components, materials, and consumables used in the manufacture of Stryker products.Qualification Knowledge SkillsBachelor's degree/ Master's in Microbiology or equivalent.2 years minimum experience as a Microbiologist (LAL/Bioburden/EM testing, Biocompatibility, Sterilization).4 years of experience as a Microbiologist (LAL/Bioburden/EM testing, Biocompatibility, Sterilization) is preferred; Master's Degree preferred.Must possess strong communication, project management, and influencing skills as well as have the ability to manage multiple tasks simultaneously.Strong interpersonal skills.Strong written and oral communication and negotiation skills.Strong critical thinking and "outside the box" thinking.Highly developed problem-solving skills.Strong analytical skills.Demonstrated ability to successfully manage and complete projects in a matrix organization.Demonstrated ability to work independently.Experience in working in a compliance risk situation.High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.Some travel may be required.
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