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Biological Quality Supervisor

ICU Medical Costa Rica LTD · Heredia

Mid 🇪🇸 Español
ISO 13485 ISO 14644 ISO 11137 ISO 11737 USP

Job description

About the role

The Biological Quality Supervisor ensures that production areas, process utilities, and medical devices meet stringent biological quality standards and regulatory requirements. This position oversees a team that conducts biological testing and drives continuous improvement in manufacturing processes.

Key responsibilities

  • Coordinate and supervise a team performing environmental, utility, and device biological tests.
  • Guarantee compliance with ISO 13485, ISO 14644, ISO 11137, ISO 11737, and USP standards.
  • Analyze test results regularly to maintain process control.
  • Investigate and resolve biological quality issues.
  • Support continuous improvement of biological control procedures in medical‑device manufacturing.

Required profile

  • University degree in Microbiology.
  • Registered microbiologist with the relevant professional college.
  • Intermediate proficiency in spoken and written English.
  • Minimum 1 year of experience supervising staff.

Required skills

  • Knowledge and application of ISO 13485, ISO 14644, ISO 11137, ISO 11737, and USP standards.
  • Proficiency with Microsoft Office, especially intermediate Excel.
  • Microbiology testing expertise.

Questions fréquentes

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Published 1 month ago

Expires 4 weeks from now

28 views · 0 interested

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ICU Medical Costa Rica LTD

Heredia