QA Engineer
Summary
QA Engineer ensures medical devices meet regulatory standards by auditing processes, resolving quality issues, and maintaining ISO 13485 compliance in a contract manufacturing environment.
Our client is a leading medical device contract manufacturer with operations in Singapore, Malaysia, and China. They are looking for QA Engineers to support quality assurance activities and ensure compliance with medical device quality standards.
Working Hours:
Monday – Friday, 8:30am – 6:00pm
Job Responsibilities
- Support and oversee Quality Assurance activities to ensure products meet customer and regulatory requirements
- Monitor manufacturing processes, investigate quality issues, and drive corrective and preventive actions (CAPA)
- Manage QA documentation, quality audits, product release, and inspection activities
- Liaise with customers, suppliers, and production teams to resolve quality-related issues
- Analyze quality data, support continuous improvement initiatives, and ensure compliance with ISO 13485 standards
Requirements
- Diploma or Degree in Engineering or a related discipline
- Minimum 2–3 years of Quality Assurance experience in a manufacturing environment
- Hands-on experience with ISO 13485 Quality Management System is required
- Experience in quality audits, process validation, CAPA, and quality documentation is preferred
- Strong analytical, problem-solving, and communication skills
Interested candidates who wish to apply for the advertised position are encouraged to click "Apply Now" to submit their application.
We regret that only shortlisted candidates will be notified.
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