QAQC Quality Engineer
Job Summary
The QAQC Engineer will manage supplier quality processes, including on-boarding, auditing, and performance monitoring within a manufacturing environment. This role involves ensuring compliance with ISO 9001, 14001, and 13485 standards through internal and external audits. Additionally, the engineer will lead root cause analysis for material defects and oversee CAPA processes to drive continuous quality improvements.
Responsibilities
- Manage supplier on-boarding and auditing processes
- Monitor supplier performance and material quality
- Lead MRB meetings and root cause analysis
- Maintain ISO 9001/14001/13485 documentation
- Conduct internal and external quality audits
Required Skills
- Diploma in Engineering or Manufacturing
- 2+ years experience in ISO documentation
- Proficiency in PFMEA, GR&R, and 8D/5W
- Knowledge of Supplier Quality Management
- Strong audit compliance skills
Job Details
Job Responsibilities:
- Participate in procedures for Supplier Management process such as supplier on-boarding, selection and approval process by assessing and evaluating supplier profile; visiting and auditing of supplier facility and process, initiating supplier quality agreement review, and establishing good partnership with suppliers.
- Evaluate and monitor supplier performance and collaboration with suppliers to identify opportunities for enhancements and improvements.
- Support new supplier/material qualification by ensuring that all supplier on-boarding related documentations and action are complete, and that quality of purchased material meets the required standards and expectations.
- Communicate and work closely with external suppliers and internal stakeholders (Procurement, Warehouse and Manufacturing) on supplier/material qualification related projects, material quality related issues.
- Address purchased material failures/defects and derive proper preventive and corrective action plans through SCAR system.
- Implement quality inspection standards on incoming and outgoing inspections.
- Responsible for timely closure of Corrective and Preventive Actions (CAPA), non-conformance investigation reports and customer complaints and publish reports on quality performance.
- Lead the Material Review Board (MRB) meeting involving members from production, engineering and quality departments to conduct root cause analysis, address quality issues, implement corrective actions and review its effectiveness.
- Maintain updated and accurate documents and records on ISO 9001, 14001 and 13485 system (includes Quality Manual, Procedures, Work Instructions, Forms etc) to ensure system compliance and ready for Management Review.
- Plan and conduct internal and external audits to ensure readiness of all sections for third party certification body, management review and customer audits.
- Review audit findings and develop action plans to drive continuous improvements.
- Perform any other duties as assigned.
Job Requirements:
- Possess minimum Diploma in Quality Management / Engineering / Manufacturing or related field with minimum 2 years of relevant working experience in handling audits and ISO documentation in manufacturing industries.
- Knowledge in Supplier Management.
- Knowledge of quality Management Standards such as ISO 9001, 14001, 13485 and ISO 22301.
- Knowledge in Potential Failure Mode Effect Analysis (PFMEA), Control Plans and Gage Repeatability & Reproducibility (GR&R).
- Familiar with 8D and 5W problem solving methodology.