Salary Negotiable based on experience
Consultant Jessie Jin
Date posted 27 February 2019 2019-02-272019-04-14 manufacturing-and-production 서울시 KR KRW 80000000 90000000 90000000 YEAR Robert Walters https://www.robertwalters.co.kr
A global medical device manufacturer is recruiting for a QA Manager. This position is responsible for Korea quality management in compliance with FDA QSR, ISO 13485, TWFDA regulation and quality requirements.
- Roll out Global SOP throughout the company and oversee quality system performance
- Plan internal audit program, quality training program and CAPA program to ensure successful achievement of quality objectives
- Provide direction and guidance to project teams to execute tactical quality projects and/or initiatives in Korea
- Lead all preparation and communications with internal and external parties
- Develop 3PL Quality capability
- Oversight Product quality, including labelling process, return inspection etc. and is authorized to dispose products
- Ensure Korea post market activities well implemented as per the requirement, including MDR, FCA etc.
- Develop Korea supplier and dealer quality management strategies. Identify possible risks and plan all activities to enhance compliance to regulation and company requirements
- Bachelor’s degree or higher in Bioscience or a related field
- Experience in pharmaceuticals, medical device areas and/or in working in multinational healthcare companies preferred
- 10+ years’ experience in quality assurance at international companies in the medical device field
- In-depth knowledge of ISO 13485 standard and local regulation pertaining to GDP, MDR and recalling
- Business level verbal and written proficiency in English
About the Company:
A medical equipment company that specializes in products used in a number of cardiovascular treatments, the organization is the leader in its field. With unique technology that is relied upon by medical professionals and institutions worldwide, this company continues to have a commanding market position.