Senior staff microbiologist

Hybrid Senior Staff Microbiologist – 12 month fixed term contractWork Flexibility: HybridPosition OverviewThe Senior Staff Microbiologist will provide technical input into the sterility compliance of Stryker products in accordance with relevant regulatory requirements and standards for medical devices, at a multi‑site / global level. The role is not lab based and requires oversight across multiple sites.ResponsibilitiesOversee environmental and utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi‑sites.Execute, review, and approve Gamma and Ethylene Oxide sterilisation validations and re‑qualifications in line with BS EN ISO standards.Assess and validate sterility supplier validation programmes.Interpret sampling and monitoring data, apply statistical and analytical techniques to determine control, trending and identify when action is required.Lead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units/sites, and review and approve CAPA.Act as the technical lead for microbiology in cross‑functional groups including product and process issues, root‑causing, projects, initiatives and business critical forums.Serve as subject‑matter expert on audit and review of supplier quality activities with critical vendors in microbiology.Mentor and train team members and cross‑functional groups (induction, GMP, etc.).Provide technical assessment for risk assessment (e.g., SofHA) in sterility and microbiology.Assess and approve acceptance of resolution to quality issues, including concession management.Support new product compliance with sites’ sterility standards and ensure successful integration into validated processes.Oversight and approval of biocompatible assessments of components, materials and consumables used in Stryker product manufacturing.Demonstrate technical supervisory capabilities and lead projects to completion.QualificationsBachelor’s degree in Microbiology or an equivalent related subject.Minimum 6 years of microbiology‑related experience and a total of 8 years in a quality/regulatory affairs environment.Experience interacting with regulatory agencies (e.g., FDA, MoH, TUV).Desirable: Lead Auditor certification.In‑depth knowledge of US and international medical device regulations and standards in microbiology.Strong communication, project management and influencing skills; ability to manage multiple tasks simultaneously.Leadership/management experience with people, strong interpersonal and written/oral communication skills.Analytical and critical‑thinking skills, including proficiency in statistical techniques, data review and analysis.Proficient with Microsoft Word, Excel and PowerPoint.Experience working in a compliance‑risk environment, leading and completing projects in a matrix organisation.Travel & FlexibilityTravel may be required – up to 10% of the time.Hybrid work model: regular work both in an alternate workplace and at a Stryker facility.
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