About the role

Aplyr's Quick Take

This role is about ensuring compliance in the medical device industry, specifically focusing on sterilization and microbiological testing. You'll conduct audits, review products, and make certification recommendations based on safety and effectiveness. It's primarily an individual contributor role requiring strong decision-making and communication skills.

Good fit

Ideal candidates have at least four years of experience as a microbiologist or sterilization engineer, preferably in medical devices. A background in quality management and familiarity with ISO standards is essential, along with the ability to communicate confidently with clients.

Worth noting

The position is remote but requires local hiring in China and Mandarin language skills. The role involves significant responsibility in making critical decisions that impact patient safety.

Great that you're thinking about a career with BSI!

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.

Aplyr's read

BSI is a global authority in standards and certification, attracting professionals dedicated to enhancing organizational performance and risk management across diverse sectors.
Synthesized from recent postings & public sources

What's promising

•BSI's global reach provides employees with international career opportunities.
•The company is a recognized leader in standards development, offering a strong reputation to leverage in your career.
•Diverse roles across sectors like medical devices and information security offer varied career paths.

What to watch

•The niche focus on standards and certification may limit creative job roles.
•High specialization in roles may require specific qualifications and experience.
•Frequent need for relocation or travel could impact work-life balance.

Why BSI

•BSI's historical legacy as a standards pioneer sets it apart in the industry.
•The company offers specialized roles in emerging sectors like ICT and medical devices.
•BSI's commitment to continuous improvement in standards provides dynamic learning opportunities.

Aplyr’s read is generated by AI from public sources. Was it useful?

About BSI

BSI

bsigroup.com

View company

BSI (British Standards Institution) is a global leader in standards development and certification services, helping organizations improve their performance and manage risk.