Quality Engineer QAQC QMS
Job Summary
The Quality Engineer will oversee supplier quality management, ISO documentation, and process audits within a manufacturing environment. Key responsibilities include conducting supplier evaluations, managing CAPA processes, and ensuring compliance with ISO 9001, 14001, and 13485 standards. The role also requires leading Material Review Board meetings and driving continuous improvement projects.
Responsibilities
- Manage supplier on-boarding, auditing, and quality performance
- Oversee CAPA, non-conformance reports, and customer complaints
- Maintain ISO 9001, 14001, 13485 compliance and documentation
- Lead Material Review Board and root cause analysis
Required Skills
- ISO 9001/14001/13485 standard knowledge
- Supplier quality management
- PFMEA, Control Plans, and Gage R&R
- 8D and 5W problem-solving
Job Details
Job Responsibilities:
- Participate in Supplier Management processes including on-boarding, selection, approval, and supplier facility auditing.
- Monitor supplier performance and identify opportunities for improvement.
- Support new supplier/material qualification and ensure purchased materials meet quality standards.
- Coordinate with Procurement, Warehouse, and Manufacturing teams on qualification projects and quality issues.
- Address purchased material failures/defects through SCAR systems and implement preventive/corrective actions.
- Implement quality inspection standards for incoming and outgoing goods.
- Manage timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints.
- Lead the Material Review Board (MRB) to conduct root cause analysis and implement corrective actions.
- Maintain accurate documentation for ISO 9001, 14001, and 13485 systems (Quality Manual, Procedures, Work Instructions).
- Plan and conduct internal and external audits to ensure compliance for third-party certifications.
- Review audit findings to develop action plans for continuous improvement.
Job Requirements:
- Diploma in Quality Management, Engineering, or Manufacturing.
- Minimum 2 years of relevant experience in manufacturing audits and ISO documentation.
- Knowledge of Supplier Management and quality standards (ISO 9001, 14001, 13485, ISO 22301).
- Proficiency in PFMEA, Control Plans, and Gage R&R.
- Familiarity with 8D and 5W problem-solving methodologies.