Senior staff microbiologist

Hybrid Senior Staff Microbiologist – 12 month fixed term contract

Work Flexibility: Hybrid

Position Overview

The 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.

Responsibilities

• Oversee 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.

Qualifications

• Bachelor’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 & Flexibility

• Travel may be required – up to 10% of the time.
• Hybrid work model: regular work both in an alternate workplace and at a Stryker facility.