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Process Improvement Specialist
2 months ago
Job Summary
The Quality Manager will oversee the quality management system, ensuring compliance and continuous improvement of processes. You will design quality standards, inspect materials, and develop corrective actions to enhance operational outputs.
Key Responsibilities
- Manage the quality department and communicate expectations.
- Lead external audits and ensure adherence to ISO 13485.
- Update and improve the Quality Management System.
- Provide guidance to non-Quality staff.
- Set and enforce quality standards and guidelines.
- Identify and resolve non-conformances.
- Implement automated testing systems.
- Review and ensure compliance with production instructions.
- Maintain cleanliness and traceability in production areas.
- Oversee goods in and out operations.
Requirements
- Over 5 years' experience in a supervisory quality role.
- Knowledge of ISO13485, UKCA, MDR standards.
- Experience in ISO quality systems (9001, 13485), preferably in the medical field.
- Engineering background with metalwork and plastic components.
- Internal auditor training in ISO standards is advantageous.
- Experience in SME environments preferred.
- Self-motivated with strong attention to detail.
- Proficient in computer applications.
Additional Duties
- Collaborate closely with directors and staff to ensure quality compliance.
- Contribute to the overall success of production and quality initiatives.
- Perform other related tasks as required.