As a Quality Engineer, you will be responsible for ensuring the quality of our products and procedures in compliance with established standards, address quality issues, drive continuous improvement, and contribute to building high-quality products that exceed customer expectations.
Job Responsibilities
- Conduct assessment and review on supplier qualification, performance and process capability.
- Ensure supplier quality issues are dealt with, analyzed, improved and follow through.
- Interact with customer on product quality. Handle and follow-up to address customer feedback/complaints.
- Support internal, external and customer audits.
- Evaluation, verification and validation of new parts/samples.
- Establish and maintain inspection criteria for incoming, in-process and final products.
- Identify quality issues, NCR, CAPA handling and drive continuous improvement.
- Authorize the release of products (COC), COA review & approval
- Monthly data analysis on product quality and quality objective
- Review and approval on DHR
- Participate in new projects, commercial product quality management and control
- Drive change management and control
Job requirements
- Bachelor's degree in relevant field with 3-5 years experience in medical device QA and/or RA
- ISO 13485:2016 certified internal auditor will be advantageous
- Familiar with quality control tools
- Strong analytical and problem-solving capability
