Quality Manager WCAN
Job Summary
The Quality Manager will oversee ISO 9001, 14001, and 13485 documentation and system compliance. The role involves coordinating internal and external audits, managing supplier quality, and leading corrective action processes. Additionally, the position supervises QC inspectors and ensures adherence to engineering drawings and quality standards.
Responsibilities
- Manage ISO documentation and compliance
- Lead internal and external audits
- Manage supplier quality and CAPA processes
- Supervise QC inspection team
- Drive continuous improvement initiatives
Required Skills
- ISO 9001/14001/13485 knowledge
- Quality Management system experience
- Audit coordination skills
- Supplier quality management
- Root cause analysis
Job Details
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.