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Technical Specialist - Microbiology
BSI
- New York, New York, United States
- New York, New York, United States
Über
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.
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.
Sprachkenntnisse
- English
Hinweis für Nutzer
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