|部署・役職名||技術専門家（ 微生物医療機器） Technical Expert － Microbiology medical devices|
Technical Specialist and Scheme Manager (Microbiology medical device) - Homebased
Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change?
We hire 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.
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 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.
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
Japanese speaking required.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at our company. They help us ensure that our company is a great place to work and a highly successful business.
We are 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.