Quality Director (Medical Device) 200-300K/Quality Assurance ManagerMRI Worldwide Recruitment (Thailand) Ltd.

Position:     Quality Director (Medical Device) 200-300K
Location:     Chachoengsao
Recruiter:   Ann (086-3784083), sirnapa(at)mriww.co.th
Send resume and call me "NOW" before someone else takes this job!
 
Job Description:
Ensures adequate resources are available and trained to implement the facility quality plan and required day-to-day activities.
Oversees the Quality Management Review process for the facility and is responsible for ensuring actions are assigned and complete.
Ensures internal audit plans are developed and deployed and builds capability for lead auditors across the site to conduct internal audits.
Provide training and awareness across the medical device business units including: Medical Device Directive 93/42/EEC where required, Medical Device Regulation 2017/745, ISO13485: 2016 - Medical devices - Quality management systems, IEC 62366-1: 2015 - Application of Usability Engineering to Medical Devices, ISO14971: 2019 - Application of risk management to medical devices, FDA QSR 21 CFR Part 820- Quality System Regulations, where/ if required
Ensures maintenance of ISO13485: 2016 across the global business
Facilitates the roll out of MDR framework requirements
Assists with management of relationships with notified bodies
Ensures the medical device QMS remains fit for purpose and up to date with new requirements as identified
 
Qualification:
Thai Nationality only
Bachelor's degree in Scientific or related field.
Extensive experience in a Manufacturing and relevant Quality role.
Demonstrated people management experience.
Working knowledge and experience with products requiring compliance to FDA medical device regulations.
A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Manager of Quality Organizational Excellence / Auditor.
Good command in English, computer.
 
Interested candidates please send your application letter with resume, current and expected salary with contact details and refers the position as
"Quality Director (Medical Device) 200-300K"
to sirinapa(@)mriww.co.th
If you believe that you are the right one,
Send your resume and Call Ann "NOW" 086-3784083