Renrui HR Hiring! Full Time Process Engineer - Quality Engineer (Medical Device Industry) in Johor - Ricebowl

Process Engineer Job Responsibilities

1. Develop, optimize, and standardize manufacturing processes for medical devices/consumables to ensure process stability, traceability, and compliance.
2. Lead New Product Introduction (NPI), including DFM review, process development, IQ/OQ/PQ validation, pilot run, mass production ramp-up, and handover.
3. Develop and update SOPs, Control Plans, PFMEA, and inspection specifications in compliance with ISO13485/ISO9001 and medical regulations.
4. Address process deviations and non-conformities; conduct RCA, CAPA, and mistake-proofing to improve yield and reduce rework/scrap.
5. Manage evaluation, acceptance, maintenance, and validation of tooling and equipment to meet medical production precision and cleanliness requirements.
6. Collaborate cross-functionally with production, quality, R&D, procurement, and suppliers to drive continuous improvement and cost optimization.

Quality Engineer Key Responsibilitie

1. Responsible for production process quality control, abnormality handling, defect analysis and improvement follow-up
2. Lead customer complaints, 8D reports, CAPA development and closure
3. Develop and maintain inspection standards, SIP, control plan, PFMEA and other quality documents
4. Drive quality improvement for incoming, in-process and finished goods to increase yield and reduce scrap
5. Participate in NPI new product introduction, conduct quality planning, first article inspection and validation
6. Support internal & external audits to ensure compliance with ISO13485 and medical device regulations
7. Coordinate with Production, Engineering, and Procurement to resolve quality issues