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Quality Assurance Manager
2 months ago
Job Summary:
The Quality Manager will oversee the quality management system, ensuring compliance and continuous improvement of processes. This role is responsible for designing quality standards, inspecting materials, and developing corrective actions to enhance operational outputs.
Key Responsibilities:
- Manage the quality department and communicate expectations to team members.
- Lead external audits and ensure adherence to regulatory standards, such as ISO 13485.
- Update and improve the Quality Management System to ensure it remains effective and efficient.
- Provide guidance and support to non-quality staff to ensure they understand and adhere to quality standards.
- Set and enforce quality standards and guidelines to ensure consistency across the organization.
- Identify and resolve non-conformances to prevent quality issues.
- Implement automated testing systems to improve quality control.
- Review and ensure compliance with production instructions to prevent quality issues.
- Maintain a clean and organized production environment to ensure traceability and quality.
- Oversee goods in and out operations to ensure quality and accuracy.
Ideal Candidate:
- Minimum 5 years of experience in a supervisory quality role, preferably in a manufacturing environment.
- Knowledge of ISO 13485, UKCA, and MDR standards, as well as experience with ISO quality systems (9001, 13485) in the medical field.
- Engineering background with experience in metalwork and plastic components.
- Internal auditor training in ISO standards is an asset.
- Experience in small to medium-sized enterprises (SMEs) is preferred.
- Self-motivated with strong attention to detail and ability to work independently.
- Proficient in computer applications and software.
Additional Duties:
- Collaborate closely with directors and staff to ensure quality compliance and alignment with business objectives.
- Contribute to the overall success of production and quality initiatives by identifying areas for improvement and implementing changes.
- Perform other related tasks as required to support the quality management system.