Technical Specialist and Scheme Manager Microbiologist

1 week ago


Chaoyang Qu, China BSI Full time

Job Title: Technical Specialist and Scheme Manager (Microbiology)


Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for a new challenge?


BSI is seeking qualified and experienced industry microbiologists to help clients navigate compliance within areas of sterilization, packaging, and microbiological testing.


In this role, you will apply your sterile medical device experience to impact patient safety and help determine which new products go to market.


Technical Specialist Responsibilities:


  • Planning, reporting, and performing audits of clients' management systems for regulatory and voluntary compliance.
  • Conducting comprehensive in-depth medical device reviews, including sterilization validation.
  • Making recommendations on certificate issuance based on objective evidence of safety and effectiveness.


The Technical Specialist – Microbiology role requires maturity to make decisions regarding benefits and risks of medical device products and recommend certification.


Please review the qualifications below and apply if you meet the criteria.


Education/Qualifications:


  • A minimum of four (4) 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 China, and Native Japanese speaking required for Japan.


BSI is conducting face-to-face interviews, but virtual interviews are also possible.



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