[담당업무]

ㆍCoordinate and participate in process validations
ㆍManage and oversee outsourced testing activities, including review of test protocols and final test reports.
ㆍConduct biocompatibility testing as necessary, ensuring compliance with relevant standards, i.e. ISO 10993 and the like.
ㆍLead risk Design risk management activities per ISO 14971, etc. Develop DFMEAs for disposables.
ㆍEnsure compliance with relevant standards including ISO 14791, ISO 11135, ISO 10993, related USP, related ASTM and ISO 13485.

[자격요건]

- Bachelor’s degree in Biomedical, Material Engineering or Natural Sciences field.

- Minimum 3 years of experience in V&V of disposable medical devices

- Working knowledge of ISO 14971, ISO 10993, and ISO 11135

- Fluent in English (Read, write, speak)