senior quality assurance specialist.

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容
Join a dynamic team dedicated to advancing healthcare through innovative quality assurance practices.
Work in a collaborative environment with opportunities for professional growth and development.
Contribute to the development and maintenance of cutting-edge medical devices and diagnostics that make a difference in people's lives.

求められる経験
Required Qualifications and Experience:
● Educational background or experience meeting the requirements for a General Marketing Authorization Holder of Class III Medical Devices (see note)
● At least 5 years of quality assurance experience in medical devices or in vitro diagnostic medical devices
● Experience in responding to QMS conformity investigations by regulatory authorities or certification bodies, or ISO 13485 conformity investigations
● Business-level English proficiency (reading technical documents, handling emails and conference calls)

Preferred Qualifications and Experience:
● Team leader or team management experience (people management experience not required) ...