Manufacturing Quality Engineer - WCAN
2 months ago
Responsibilities:Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instru.....
Responsibilities:
- Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
- Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
- Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
- Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
- Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
- Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
- Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
- Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
- Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
- Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
- Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
- Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.
Qualifications:
- Diploma in Quality Management, Engineering, Manufacturing, or a related field.
- Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
- Basic understanding of supplier management and quality coordination.
- Familiarity with commonly used quality management standards (e.g. ISO systems).
- Working knowledge of quality tools and process control methods.
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