Quality Engineer
Job Summary
The Quality Engineer will maintain the Quality Management System (QMS) and drive quality improvements. You will work closely with the Assistant Quality Manager to manage suppliers and ensure material quality standards. The role also involves leading internal quality audits and managing corrective actions to ensure ISO compliance.
Responsibilities
- Manage supplier quality and on-boarding processes
- Oversee CAPA and non-conformance investigations
- Lead Material Review Board meetings
- Conduct internal and external quality audits
- Maintain ISO 9001, 14001, 13485 compliance
Required Skills
- ISO Quality Standards (9001, 14001, 13485)
- Supplier Management
- PFMEA, Control Plans, and GR&R
- 8D and 5W problem solving
- Audit documentation experience
Job Details
Responsibilities:
- Participate in Supplier Management processes including on-boarding, selection, approval, and facility audits.
- Evaluate and monitor supplier performance to identify opportunities for enhancement.
- Support new supplier/material qualification by ensuring all documentation and quality standards are met.
- Collaborate with internal stakeholders (Procurement, Warehouse, Manufacturing) and external suppliers on quality projects and SCAR system management.
- Implement quality inspection standards for incoming and outgoing materials.
- Manage Corrective and Preventive Actions (CAPA), non-conformance investigations, and customer complaints.
- Lead the Material Review Board (MRB) to conduct root cause analysis and implement corrective actions.
- Maintain documentation and records for ISO 9001, 14001, and 13485 systems.
- Plan and conduct internal and external audits to ensure compliance.
- Review audit findings and develop action plans for continuous improvement.
Qualifications:
- Diploma in Quality Management, Engineering, Manufacturing, or related field.
- Minimum 3 to 5 years of relevant working experience in audits and ISO documentation in manufacturing.
- Knowledge in Supplier Management and Quality Management Standards (ISO 9001, 14001, 13485, ISO 22301).
- Experience with PFMEA, Control Plans, GR&R, 8D, and 5W methodology.
- Strong communication, presentation, and organizational skills.
- Positive attitude, ability to multi-task, and capable of working independently or in a team.