Quality Assurance Engineer (Plastics Injection ISO 13485)x2

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.

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

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

If you are interested in the position

Please include your availability, expected salary and reason for leaving current job

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913