Support on all Integrated Management System (IMS) relevant activities, with reference to ISO 9001, ISO 14001, ISO 13485 and SS 620 standards requirement.

• Assess the quality management arrangement for subcontracting & purchasing activities.
• Provide management information on quality management.
• Overall reviewer to ensure completeness & compliance of site’s IMS / QMS / EMS activities, documentation & processes.
• Plan & handle internal & external (certification & customer) audits relevant to the site.
• Identify deficiencies, resolve problems & implement solutions affecting the IMS / QMS.
• Support other delegated IMS or project tasks.
• For ISO 13485, perform medical device file & medical device product release review.
• Initiate & manage the timely completeness of customer complaints, actions implementation, effectiveness review & report completion.
• To execute Vendor Performance Assessment Program.
• Ensure & verify timely corrective action is performed.

• Meticulous in work & willing to learn.
• Willing to take on any new work assigned by higher management.
• Able to work independently in a fast-paced environment.