Senior QA Executive, Asean

7 days ago


Singapore INTEGRITY PARTNERS PTE. LTD. Full time

Medical Device MNC with regional responsibilities
- Competitive renumeration
- Leading technological innovations specialising in Orthopaedics

**JOB DESCRIPTION**

The successful incumbent will be handling quality related activities in the ASEAN market, enduring compliance to corporate quality requirements affecting company operations and products.
- Maintaining document control, ensuring completeness, accuracy and comment security.
- Post-market surveillance, complaint management, field actions, adverse event reporting in ASEAN, loaner set inspection
- Liaising with distributors and third party suppliers as well as supporting warehouse quality activities
- Leading supplier and internal audits to ensure compliance and effectiveness of QMS
- Initiate CAPA and follow-up to closure as necessary to ensure overall quality compliance
- Lead and drive quality implementation projects
- Perform analysis of internal quality date to prepare management reports on quality metrics

**REQUIREMENTS**
- Relevant Bachelor’s Degree (e.g. Biomedical, Bioengineering)
- 5 years’ experience in a medical device company with regional exposure (ASEAN/APAC) managing elements of the quality system
- Fluent understanding of ASEAN quality requirements and regulations
- Working experience in implementation and maintenance of quality standards (e.g. GDPMDS, ISO13485)
- Great interpersonal skills with internal and external stakeholder management
- Resourceful and inquisitive - able to comprehend technical/engineering/medical terminology or able to reference literature for better understanding
- Proactive, independent and a great team player

**HOW TO APPLY**

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502



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