Quality Engineer (Supplier Quality Function)

CORE JOB RESPONSIBILITIES:
List the essential job responsibilities in descending order of importance.
1. Be responsible for quality control of the products manufactured by suppliers located in Vietnam. Responsibilities include but are not limited to new supplier process control set up, process audits, CAPAs/SCARs, supplier trainings, data collection and analysis, product testing, development of quality related methodology, etc.
2. Ensure the suppliers are clear on Medline and International quality standards, processes and procedures for medical device manufacturing.
3. Work with the suppliers to implement and maintain sufficient GMP and quality systems, including IQC, IPQC, FQC, good documentation practices, calibrations, maintenance, etc.
4. Work with supplier to validate the production parameters and ensure the supplier properly document and verify these parameters once implemented.
5. Work with Medline Shanghai and US team to determine appropriate testing parameters for the products to ensure limited failures in the field.
6. Work closely with suppliers, the Shanghai office and the corporate office in the USA to lead product changes and improvements.
7. Lead the root cause investigations and analysis for quality issues such as customer complaints and inspection rejections. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
8. Cooperate with multiple departments such as sourcing, logistics, QA/QC to drive new product/supplier development projects and meet with business prospects.