Quality Engineer QAQC QMS
Job Summary
The Quality Engineer will be responsible for managing supplier quality processes, including on-boarding, auditing, and performance monitoring. The role involves maintaining compliance with ISO standards such as 9001, 14001, and 13485 while leading root cause analysis and corrective action initiatives. You will work closely with cross-functional teams to ensure high standards in incoming and outgoing material quality.
Responsibilities
- Manage supplier on-boarding, auditing, and performance.
- Oversee CAPA, non-conformance, and customer complaint reports.
- Maintain ISO 9001/14001/13485 compliance and documentation.
- Lead MRB meetings and root cause analysis.
- Execute incoming and outgoing quality inspections.
Required Skills
- ISO 9001, 14001, 13485 knowledge
- Supplier Quality Management
- PFMEA and Gage R&R proficiency
- 8D and 5W problem solving
- Auditing experience
Job Details
Job Responsibilities:
- Participate in Supplier Management processes, including on-boarding, selection, approval, and supplier facility auditing.
- Evaluate and monitor supplier performance and identify opportunities for improvements.
- Support new supplier/material qualification to ensure documentation is complete and purchased materials meet quality standards.
- Communicate with internal stakeholders (Procurement, Warehouse, Manufacturing) and external suppliers regarding qualification projects and quality issues.
- Address purchased material failures/defects and derive preventive/corrective actions through the SCAR system.
- Implement quality inspection standards for incoming and outgoing inspections.
- Manage Corrective and Preventive Actions (CAPA), non-conformance investigation 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 to ensure compliance.
- Plan and conduct internal and external audits to ensure readiness for third-party certification and management reviews.
Job Requirements:
- Minimum Diploma in Quality Management, Engineering, or Manufacturing.
- At least 2 years of relevant experience in auditing and ISO documentation within manufacturing industries.
- Knowledge of Supplier Management and Quality Management Standards (ISO 9001, 14001, 13485, ISO 22301).
- Proficiency in PFMEA, Control Plans, and Gage R&R.
- Familiarity with 8D and 5W problem-solving methodologies.