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Quality Assurance Specialist
2 weeks ago
We are seeking a seasoned Quality Assurance Specialist to drive quality improvements and maintain our quality management system.
Key Responsibilities:- Maintain accurate ISO 9001, 14001, and 13485 documentation and records to ensure compliance.
- Plan and conduct internal and external audits to ensure readiness for certification bodies and customer audits.
- Coordinate with stakeholders to participate in customer or supplier audits.
- Review audit findings and develop action plans to drive continuous improvements.
- Generate and review quality reports on suppliers' performance and address non-conforming materials.
- Issue and follow up on Supplier Corrective Action Requests (SCAR) to suppliers.
- Support the qualification of new suppliers and maintain a healthy pipeline of qualified suppliers.
- Conduct regular reviews of calibration and preventive maintenance for equipment.
- Address quality issues arising from production and customer feedback.
- Degree in quality management, engineering, manufacturing, or related field.
- Minimum 3 to 5 years of experience in handling audits and ISO documentation.
- Knowledge in Supplier Management and quality Management Standards such as ISO 9001, 14001, 13485, and ISO 22301.
- Knowledge of potential failure mode effect analysis, control plans, and Gage Repeatability & Reproducibility (GR&R).
- Familiarity with 8D and 5W problem-solving methodology.
- Preventive Maintenance
- CAPA
- Quality Management
- Quality Assurance
- ISO
- Investigation
- Root Cause Analysis
- Drawing
- Problem Solving
- Compliance
- ISO 9001
- Audits
- PFMEA
- Manufacturing
- Audit
- Calibration
As a Quality Assurance Specialist, you will be responsible for driving quality improvements and maintaining our quality management system. If you have a strong background in quality management and are passionate about delivering high-quality results, we encourage you to apply.