Advisor, operations quality (sterilization, cleanroom & lab integrity)

About the Role

The Quality Advisor (Sterilization Engineer) provides expert technical leadership, consultation, and oversight for all sterilization processes, cleanroom operations, and microbiological controls related to sterile medical devices. This role serves as the technical authority for the final quality release of sterile devices, leads the strategic design and implementation of in-house testing laboratories, and manages crucial contamination control pillars including environmental monitoring and facility pest control compliance. Additionally, the Advisor proactively identifies and executes process improvement projects to optimize lead times, reduce testing costs, and maintain strict GMP compliance.

Performs tasks such as:

Internal Lab Implementation: Lead strategy, design, equipment qualification (IQ/OQ/PQ), and setup of internal microbiological testing labs to transition outsourced testing in-house Contamination & Pest Control: Oversee the Facility P...

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