Job Description 

• Thorough knowledge in quality management system, clear concept in operation and production complied with regulatory standards and requirement (FDA / ISO13485).
• Documentation and record control in accordance with standard and procedural requirements (such as FDA / ISO 13485 etc).
• Collaborate with departments to ensure validation and compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines.
• Perform ad hoc duties as assigned.

Requirements

• Degree holder in life science and/or engineering related discipline, with at least 3 years of experience in manufacturing/QA environments.
• Knowledge of FDA regulations and updates. Quality certifications (such as CE 0470, IEC60601, KEMA etc).
• Experience in ISO 9001, ISO 13485 is an advantage.
• Ability to manage multiple tasks concurrently in a dynamic environment.
• Independent, detailed mind and strong analytical skill.
• Production management experience is a plus

Salary will be commensurate with qualification and experience. Interested parties please email your C.V. with expected salary and availability by clicking "Apply Now".

Data held by the Company relating to employment applications will be kept confidential and used only for processing applications. The Company will retain their applications for a maximum period of six months.

A US listed medical device company based in Hong Kong is looking for :