Senior Quality Assurance Engineer
12 hours ago
We are seeking a highly skilled Senior / Product Quality Engineer to join our team at EA Recruitment Pte Ltd. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our medical devices.
Key Responsibilities:- Conduct thorough assessments and reviews of supplier qualifications, performance, and process capabilities.
- Identify and address quality issues, analyze and improve processes, and ensure follow-through on supplier quality issues.
- Collect, handle, and follow up on customer feedback and complaints.
- Support internal, external, and customer audits, ensuring compliance with ISO 13485:2016.
- Evaluate, verify, and validate new parts and samples, establishing and maintaining inspection criteria for incoming, in-process, and final products.
- Drive continuous improvement by identifying quality issues, handling NCRs, and implementing CAPAs.
- Authorize the release of products, review and approve COAs, and perform monthly data analysis on product quality and quality objectives.
- Review and approve DHRs, participate in new projects, and drive change management and control.
- Possess a minimum Diploma/Degree in a relevant subject area with 3-5 years' experience in medical device QA and/or RA.
- ISO 13485:2016 certified internal auditor is an advantage.
- Familiarity with quality control tools is essential.
Candidates are encouraged to apply with a resume that includes work experiences, job responsibilities, current and expected salary, reason for leaving, date of availability, and education background.
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