Technical Specialist - Microbiology

BSI; Poplar Bluff (MO); Remote; USD 70,000 - 90,000; Full time

Job summary

A global standards organization is seeking a Technical Specialist and Scheme Manager in Microbiology to evaluate medical devices for compliance with sterilization standards. Candidates should have four years of experience in microbiology or sterilization engineering, proficiency in ISO 13485, and quality management experience. The role is flexible, with remote work options available.

Qualifications

• Minimum four years’ experience as a microbiologist or sterilization engineer.
• Thorough knowledge of ISO 13485 and familiarity with MDD/MDR.
• Quality management experience with participation in third-party audits.

Responsibilities

• Plan and perform audits ensuring compliance with regulatory requirements.
• Conduct medical device reviews and make certification recommendations.
• Communicate effectively with clients about complex decisions.

Skills

Microbiology

Sterilization Engineering

Quality Management

Client Communication

ISO 13485 Knowledge

Education

Bachelor’s degree in Microbiology or related scientific field

Job description

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 asterile 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.