機械（自動車/プラント/精密機器） - 基礎研究開発
echnical 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.
For over 100 years BSI has shaped standards of excellence adopted by organizations world-wide.
•BSI began in 1901 with the 1st meeting of the engineering Standards Committee, convened by John Wolfe-Barry, designer of London’s Tower Bridge.
•In 1903 our Kitemark was registered and as such is one of the oldest Trustmarks still in use today.
•BSI was the first National Standards Body and a founding member of the International Organization for Standardization (ISO).
•Our 3rdGeneration of Standards are centred around behaviour and values to help organizations reach their full potential through their people.
|勤務時間||9 to 6|
•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.