Technical Specialist Microbiologist

3 weeks ago


Chaoyang Qu, China BSI Full time

We have a career opportunity for a Technical Specialist in Microbiology with BSI. This role involves working with clients to ensure compliance with regulatory requirements, including audits and medical device reviews. The ideal candidate will have a strong background in microbiology and experience with ISO 13485. If you are a motivated professional looking to make a difference in patient safety, please consider this opportunity.

Responsibilities:
  • Plan, report, and perform audits of clients' management systems to ensure compliance with regulatory requirements.
  • Conduct comprehensive medical device reviews, including sterilization validation.
  • Make recommendations regarding certification based on objective evidence of safety and effectiveness.

The Technical Specialist - Microbiology role requires maturity and decision-making skills. The individual must be able to communicate effectively with clients and work in a collaborative environment. If you have a strong background in microbiology and experience with medical device regulations, please apply for this position.

Qualifications:

  • 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 participation in third-party quality audits.
  • Native language proficiency in Mandarin or Japanese may be required for roles in China or Japan, respectively.

At BSI, we value client-centricity, agility, and collaboration. If you are a motivated professional looking to make a difference in patient safety, please consider this opportunity.



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