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Quality Specialist (Medical Device) #MCA


Company Background:

An American medical technology company. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter.

Job Descriptions:

  • In charge of supplier management such as maintenance of the supplier filing
  • Tracking of training for all employees for on time completion
  • Manage the training needs for employees and work as country change leader
  • In charge of Quality Management System, work with cross-functional team on NCR, CAPA, and Product Risk Assesment (PRA) Process, including the required document preparation in a timely manner. Follow up CAPA and NCR action plan
  • Work as NCR/CAPA owner for SEA region
  • Develop NCR/CAPA owner in stakeholder function 
  • Collect Quality data for Quarterly Management / other reviews
  • Collect all new regulation announcement via RI platform, track all new regulations impacting EW QMS in SEA countries till implementation completion
  • Coordinate with EU CHU for all MRDS in SEA countries for timely submission
  • Work closely with Trouble Shooting Center (TSC) engineer for implementation of all servicing related procedures
  • Support in Qualification / Validation of equipment
  • Review and approve calibration reports and produce release activities

Job Requirements:

  • Minimum 5 years experience in managing capital equipment QMS
  • Has background in medical device or equipment company 
  • Bachelor's degree from Electrical Engineer or related field
  • Must have good English communication and written skills
  • Can work independently without supervision 
  • Looking for decision maker






Kuala Lumpur

Employment Type

Contract / Temp


MYR 4, 501- MYR 6, 000 / mth

To apply online please click the 'Apply' button below. For email a detailed resume in Word format to Cyndi Aw.

For further discussion about this role, please find contact details of Cyndi Aw as below:
Tel: 03-27138830
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.