Biological Quality Supervisor
ICU Medical Costa Rica LTD · Heredia
Descripcion del puesto
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 role combines team leadership with technical oversight to maintain product safety and compliance.
Key responsibilities
- Coordinate and supervise a team performing biological testing on environments, utilities, and medical devices.
- Verify compliance with quality and safety requirements, including ISO 13485, ISO 14644, ISO 11137, ISO 11737, and USP.
- Conduct periodic analysis of test results to control processes and identify trends.
- Investigate and resolve biological quality issues.
- Support continuous improvement of biological control processes in medical device manufacturing.
Required profile
- Bachelor's degree in Microbiology.
- Registered microbiologist with the appropriate professional board.
- Intermediate English proficiency (spoken and written).
- Minimum 1 year of experience supervising staff.
Required skills
- Microbiology expertise.
- Knowledge and application of ISO 13485, ISO 14644, ISO 11137, ISO 11737, and USP standards.
- Proficiency with Microsoft Office, especially intermediate Excel.
What we offer
- Hybrid work arrangement.
- Opportunity to work in a regulated medical‑device environment.
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ICU Medical Costa Rica LTD
Heredia
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