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Job title: Technical Specialist and Scheme Manager Microbiology
Location: China homebased
Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change?
BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. In this role you will have the opportunity to apply your sterile medical device experience to impact patient safety and help determine which new products go to market.
Technical Specialist Responsibilities:
Responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements.
Conduct comprehensive in-depth medical device reviews (including sterilization validation).
Make recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective.
The Technical Specialist – Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed 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
CCAA nice to have, Mandarin speaking required and local hire.
#LI-REMOTE
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
Skills Required
- A minimum of four years' experience as a microbiologist or sterilization engineer
- Bachelor's degree in Microbiology, Biology or related scientific degree
- Thorough knowledge of ISO 13485 quality standard
- Familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)
- Quality management experience including participation in third party quality audits
- CCAA certification is a nice to have
- Mandarin speaking is required
BSI Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BSI and has not been reviewed or approved by BSI.
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Flexible Benefits — Flexible benefits are positioned as part of the MyReward approach, allowing tailoring based on local eligibility and individual needs. Core elements like life assurance, income protection, and EAP access are framed as consistent pillars even as specifics vary by country.
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Leave & Time Off Breadth — Leave offerings are described as generous in certain markets, including annual leave starting around 27 days where that is standard and, in some U.S. postings, about four weeks of PTO plus a set holiday calendar. Additional time-off practices like occasional year-end office closure are also described as part of the overall package in some teams.
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Wellbeing & Lifestyle Benefits — Well-being support is presented as visible at the corporate level, including EAP access and expanded programs such as menopause support and mental-health first aid. Flexible work under “Smart Working” is repeatedly positioned as a work–life balance and inclusion lever that complements the total rewards package.
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