Quality Engineer for Medical Device Quality Assurance
2 weeks ago
We are seeking a Quality Engineer to join our team at EA Recruitment Pte Ltd. As a Quality Engineer, you will be responsible for ensuring the quality of our medical devices and processes.
Key Responsibilities:
- Conduct supplier qualification, performance, and process capability assessments
- Ensure supplier quality issues are dealt with, analyzed, improved, and followed up on
- Collect, handle, and follow up on customer feedback and complaints
- Support internal, external, and customer audits
- Evaluate, verify, and validate new parts and 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 and review and approval of COA
- Perform monthly data analysis on product quality and quality objectives
- Review and approve DHR and participate in new projects and commercial product quality management and control
Requirements:
- Possess a Diploma or Degree in a relevant subject area with 3 years' experience in medical device QA and/or RA
- ISO 13485:2016 certified internal auditor will be advantageous
- Familiar with quality control tools
Candidates with relevant experience are encouraged to apply with their resume.
We regret that only shortlisted candidates will be contacted.
EA Recruitment Pte Ltd
EA License No: 21C0492
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