QRA / QRA Section Head – Medical Device

About the role

Establishing, monitoring and maintaining the quality system implementations in accordance with the ISO 13485:2016, MDA Malaysia, US-FDA QSR, European MDR and related International Medical Device Regulations.

What you’ll be doing

• Responsible to assist in monitoring and tracking of company quality objectives.
• Responsible to manage quality document control system in accordance with the ISO 13485:2016 quality management system, US-FDA QSR, European MDR and related International Medical Device Regulations.
• Responsible to co-ordinate internal audit and conduct process audit in accordance with ISO 13485 quality management system, US-FDA QSR, EU European MDR and related International Medical Device Regulations.
• Responsible to coordinate for in-house preparation prior to external audit by certification body or customers.
• Responsible to manage the entire process of product registration of current and new produ...