Quality Engineer
Job Summary
The Quality Engineer will oversee supplier quality management, including onboarding, auditing, and performance monitoring to ensure material standards. You will manage corrective and preventive actions (CAPA) and lead Material Review Board (MRB) meetings to address manufacturing defects. Additionally, the role involves maintaining ISO 9001, 14001, and 13485 documentation and conducting internal and external audits.
Responsibilities
- Manage supplier onboarding, audits, and performance monitoring
- Oversee CAPA processes and resolve material defects
- Lead Material Review Board (MRB) activities
- Maintain ISO documentation and compliance (9001, 14001, 13485)
- Execute internal and external quality audits
Required Skills
- ISO 9001, 14001, 13485, 22301 knowledge
- PFMEA, Control Plans, and Gage R&R
- 8D and 5W problem-solving
- Supplier quality management
- Manufacturing audit experience
Job Details
Job Responsibilities:
- Participate in Supplier Management procedures, including supplier on-boarding, selection, approval, facility auditing, and quality agreement reviews.
- Evaluate and monitor supplier performance to identify enhancement opportunities.
- Support new supplier/material qualification by ensuring documentation completeness and material standard compliance.
- Collaborate with internal stakeholders (Procurement, Warehouse, Manufacturing) and suppliers to resolve material failures/defects using the SCAR system.
- 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 Material Review Board (MRB) meetings to conduct root cause analysis and implement corrective actions.
- Maintain updated documentation for ISO 9001, 14001, and 13485 systems for compliance.
- Plan and conduct internal and external audits to ensure readiness for certification bodies and customers.
- Review audit findings and develop action plans for continuous improvement.
Job Requirements:
- Diploma in Quality Management, Engineering, Manufacturing, or related field.
- Minimum 2 years of relevant experience in audits and ISO documentation within manufacturing industries.
- Knowledge of Supplier Management and Quality Management Standards (ISO 9001, 14001, 13485, ISO 22301).
- Proficient in PFMEA, Control Plans, and Gage R&R.
- Familiarity with 8D and 5W problem-solving methodology.