Microbiology Technical Specialist

A company is looking for a Technical Specialist and Scheme Manager (Microbiology) for a remote position.

Key Responsibilities :

Plan, report, and perform audits of clients' management systems for compliance with regulatory and voluntary requirements

Conduct comprehensive medical device reviews including sterilization validation

Make recommendations regarding certification based on objective evidence of device safety and effectiveness

Required Qualifications :

A minimum of four years' experience as a microbiologist and / or sterilization engineer for a sterile medical device manufacturer

Bachelor's degree (or higher) in Microbiology, Biology, or a related scientific degree

Familiarity with Gamma and EO sterilization

Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD) / EU Medical Device Regulation (MDR)

Quality management experience with significant participation in third-party quality audits