QMS Quality Engineer (Plastics Injection Molding ISO 13485)
About the company
My client is a specialized manufacturer in the contract manufacturing space. They are a Singapore based company and with their innovative technology, this is a great brand to join at an exciting time in their development.
Your tasks
about the job
- Plan, coordinate and oversee all Quality Assurance activities in the Company
- Oversee the Documentation Control function for Quality Management System
- Act as the Quality Management Representative for the Company
- Develop and implement plans to collect quality data at in-process, final inspection, test and inspection stations
- Plan and execute annual Internal Audit to ensure all quality systems and procedures are effectively implemented and auditable at all times
- Manage first article inspections and sample evaluation activities
- Partner with engineering and local suppliers to address quality issues at the source. Support design transfers, process validations (IQ/OQ/PQ), and perform PFMEAs for new projects
- Oversee incoming, in-process, and final End-Of-Line (EOL) testing and inspections
- Manage first article inspections (FAI), maintain Device History Records (DHR), and perform final quality sign-off for product release
Requirements
job requirement
- Bachelor’s Degree in Mechanical, Biomedical, Electrical Engineering
- 3+ years of Quality Engineering experience in a high-volume plastics injection or regulated medical device manufacturing environment
- High volume manufacturing environment
- Deep understanding of ISO 13485 and FDA 21 CFR Part 820
- Proven experience writing and executing NCRs, CAPAs, deviation reports, and process validations (IQ/OQ/PQ)
- Proficiency in reading engineering drawings/GD&T and using measurement/inspection tools
How to apply
If you are interested in the position Please include your availability, expected salary and reason for leaving current job