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Quality Assurance Director
2 months ago
Job Summary:
We are seeking a highly skilled Quality Assurance Manager to lead our quality department and drive regulatory compliance at Pertemps Network Group. As a key member of our team, you will play a pivotal role in ensuring the safety and integrity of our products.
Key Responsibilities:
- Quality Department Leadership: Communicate expectations, lead external audits, and ensure adherence to ISO 13485 while setting and enforcing quality standards.
- Quality Management System: Update and improve the Quality Management System to ensure compliance with regulatory requirements.
- Automated Testing: Implement automated testing to identify and resolve non-conformances.
- Production Area Management: Maintain cleanliness and traceability in production areas and review compliance with regulatory requirements.
Requirements:
- Regulatory Knowledge: Knowledge of ISO13485, UKCA, MDR standards with over 5 years' experience in a supervisory quality role.
- Quality Systems: Experience in ISO quality systems (9001, 13485), preferably in the medical field - Internal auditor training in ISO standards is advantageous.
- Engineering Background: Engineering background, with metalwork and plastic components within an SME environment, preferred.
- Personal Qualities: Self-motivated with strong attention to detail and proficient in computer applications.
Additional Responsibilities:
Collaborate closely with directors and staff to ensure quality compliance and contribute to the overall success of production and quality initiatives.