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Quality Professional
3 weeks ago
We are seeking a Quality Assurance Specialist to drive quality improvements and maintain our quality management system. This role is critical in delivering high-quality products for our customers.
The successful candidate will be responsible for maintaining accurate documents and records on ISO 9001, 14001, and 13485 systems. They will plan and conduct internal and external audits to ensure readiness for third-party certification bodies and customer audits. Additionally, they will coordinate with internal stakeholders for customer or supplier audits, review audit findings, and develop action plans for continuous improvements.
Key Responsibilities- Maintain accurate documents and records on ISO 9001, 14001, and 13485 systems.
- Plan and conduct internal and external audits to ensure readiness for third-party certification bodies and customer audits.
- Coordinate with internal stakeholders for customer or supplier audits.
- Review audit findings and develop action plans for continuous improvements.
- Generate quality reports on suppliers' performance and work with suppliers to address non-conforming materials.
- Issue and follow up on Supplier Corrective Action Requests (SCARs) and monitor their effectiveness.
- SUPPORT THE QUALIFICATION OF NEW SUPPLIERS AND MAINTAIN A HEALTHY PIPELINE OF QUALIFIED SUPPLIERS.
- Maintain and review calibration and preventive maintenance for equipment.
- Resolve quality issues arising from production and customer feedback.
- CLOSE CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS), NON-CONFORMANCE INVESTIGATION REPORTS, AND CUSTOMER COMPLAINTS IN A TIMELY MANNER.
- LEAD THE MATERIAL REVIEW BOARD (MRB) MEETING TO CONDUCT ROOT CAUSE ANALYSIS AND ADDRESS QUALITY ISSUES.
- Diploma in quality management/engineering/manufacturing or related field.
- Minimum 3-5 years of relevant working experience in handling audits and ISO documentation in manufacturing industries.
- Knowledge of quality management standards such as ISO 9001, 14001, 13485, and ISO 22301.
- Familiarity with 8D and 5W problem-solving methodologies.
This role offers a challenging opportunity to grow professionally and contribute to the success of our organization.
