Quality Engineer (Medical Device Industry)
R
Renrui HR
📍 kulai, johor, Malaysia
Job Description
- Responsible for production process quality control, abnormality handling, defect analysis and improvement follow-up
- Lead customer complaints, 8D reports, CAPA development and closure
- Develop and maintain inspection standards, SIP, control plan, PFMEA and other quality documents
- Drive quality improvement for incoming, in-process and finished goods to increase yield and reduce scrap
- Participate in NPI new product introduction, conduct quality planning, first article inspection and validation
- Support internal & external audits to ensure compliance with ISO13485 and medical device regulations
- Coordinate with Production, Engineering, and Procurement to resolve quality issues