Biological Quality Supervisor
ICU Medical Costa Rica LTD · Heredia
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.
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Published 1 month ago
Expires 4 weeks from now
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ICU Medical Costa Rica LTD
Heredia
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