Senior QA Executive, Asean

4 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

I am partnering a prominent **medical device MNC **with a global presence in orthopedic technology and innovations to seek a **Senior Quality Assurance Executive, ASEAN **to handle quality related activities in the **ASEAN markets **, ensuring compliance to corporate quality requirements affecting regional company operations and products.

**Main Responsibilities**:

- Documentation controls, ensuring accuracy and completeness as well as document security.
- Performs quality related activities such as complaint management, field actions, adverse event reporting in ASEAN, loaner set inspection
- Post-market surveillance, complaint management, field actions, adverse event
- Communicate with and support distributors, 3rd-party suppliers, warehouse quality activities
- Leads supplier and internal audits ensuring effectiveness of quality management system
- Initiate and follow-up with corrective actions necessary to ensure overall quality compliance
- Lead and drives quality implementation projects
- Perform analysis of internal quality data and prepare management reports on quality metrics

**Requirements**:

- Relevant Bachelor’s Degree (e.g. Science or Engineering discipline)
- **5 years **of direct experience in administration of quality system elements within a medical device organization within the ASEAN market
- Knowledge and a clear understanding of ASEAN quality requirements and regulations
- Working experience in implementation and maintenance of relevant quality standards, e.g. GDPMDS, ISO 9001, ISO 13485
- Excellent interpersonal skills - Internal and external stakeholders management
- Ability to work in fast paced environment and handle multiple tasks and requests
- Resourceful and inquisitive, able to comprehend technical/engineering/medical terminology or able to reference literature for better understanding

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

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