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Senior Microbiologist

3 weeks ago


Cork, Cork, Ireland recruitireland - jobboard Full time

CareerWise Recruitment is currently seeking a Site Microbiologist for a leading medical device company. This role offers a highly competitive hourly rate and an exciting opportunity to work with a global industry leader.

Key Responsibilities:

  • Lead and standardize environmental and utility monitoring, bioburden, and endotoxin testing across multiple global sites.
  • Analyze monitoring data using statistical tools, identifying trends and initiating actions as needed.
  • Provide expert input into non-conformances (NCs) and corrective/preventive actions (CAPAs).
  • Be the technical lead for cross-functional projects, product investigations, and process improvements.
  • Act as Subject Matter Expert (SME) during supplier audits and external regulatory inspections.

Requirements:

  1. 6 + years' experience in Quality or Regulatory Affairs within the medical device industry.
  2. Minimum Microbiology Degree or equivalent.
  3. Strong knowledge of FDA, ISO, and global regulatory standards related to sterility and microbiology.
  4. Experience leading regulatory inspections and supplier audits – Lead Auditor certification is a plus.
  5. Proven ability to lead projects, solve problems, and influence cross-functional teams.