Quality Engineer (Medical Device Industry)
Provides statistical support to QA, R&D and Operations
Certified ISO 13485 internal or lead auditor
About Our Client
Our client is expanding their team in Singapore and they are looking for a Quality Engineer (Medical Device Industry) who will be the the main quality engineer for supplier management program and distribution/logistic activities and responsible for conducting data analysis and provides statistical support to QA, R&D and Operations.
As Quality Engineer (Medical Device Industry) you will be reporting to Director of Quality Assurance & Regulatory Affairs and your responsibilities will include but not limited to;
- Participate in new/modified product development projects as a technical reviewer
- Monitor and act as quality reviewer for Customer Order Fulfilment and Distribution/Logistic activities
- Monitor and track CAPA, NC, Complaint, Equipment Calibration/Maintenance, Environmental Monitoring,
- Perform data analysis on Post-Market Surveillance, data (CAPA, NC, complaint), Product/Process Quality Metric, Quality Objective and Management Review.
- Manage supplier program and its performance review.
- Lead or participate in software implementation projects in areas such as Manufacturing, Operations and QMS
- Work with contract manufacturer on manufacturing process monitoring and measurement
- Conduct internal audit and supplier audit, as assigned
The Successful Applicant
The ideal Quality Engineer (Medical Device Industry) that we are looking for should have:
- Bachelor's degree or diploma in Science, Engineering, Quality or similar discipline
- 5 or more years in technical role such as Quality, R&D or Operations in medical device, automotive or other regulated industry
- Direct hands-on experience in statistical data analysis and process validation/monitoring required
- Prior working experience in supplier management, distribution environment advantageous
- Good understanding of ISO 13485, EU Medical Device Directive and FDA QSR Part 820
- Certified ISO 13485 internal or lead auditor
What's on Offer
- Continuous development and career advancement opportunities within the organisation.