Senior Microbiology Specialist

4 days ago


Chaoyang Qu, China BSI Full time

We are seeking an experienced Senior Microbiology Specialist to join our team in China or Japan.

Job Description

In this role, you will be responsible for planning, reporting and performing audits of clients' management systems to ensure compliance with regulatory and voluntary requirements. You will also conduct comprehensive medical device reviews, including sterilization validation, and make recommendations on certification.

This is a challenging opportunity for a qualified microbiologist or sterilization engineer looking to advance their career in quality assurance.

About the Role
  • Plan, report, and perform audits of clients' management systems to ensure compliance with regulatory and voluntary requirements.
  • Conduct comprehensive medical device reviews, including sterilization validation.
  • Make recommendations on certification based on objective evidence that the device is safe and effective.
Requirements
  • A minimum of four years' experience working as a microbiologist and/or sterilization engineer for a sterile medical device manufacturer.
  • Bachelor's degree (or higher) in Microbiology, Biology, or related scientific degree.
  • Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR).
  • Quality management experience including significant participation in third-party quality audits.
  • Native Mandarin speaking required for roles in China.
  • Native Japanese speaking required for roles in Japan.
About BSI

BSI is a leading global provider of testing, inspection, and certification services. We help organizations navigate complex regulations and standards to ensure safety and quality.

What We Offer

We offer a competitive salary and benefits package, including opportunities for professional development and career advancement.



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