Quality Assurance Manager
2 weeks ago
Job Title: Quality Manager - Medical Devices
Location: Bedfordshire
We are seeking an experienced Quality Manager to lead and motivate a talented team of quality professionals in the medical device industry. As a Quality Manager, you will oversee and enhance a newly implemented Quality Management System (QMS), ensuring top-tier compliance and continuous improvement.
Key Responsibilities:
- Lead, mentor, and motivate a team of quality professionals with varying levels of experience. Foster a culture of continuous improvement, trust, and collaboration.
- Take ownership of the newly implemented Quality Management System (QMS), ensuring it meets regulatory requirements and aligns with company standards. Drive continuous improvements to enhance its effectiveness and efficiency.
- Ensure compliance with all relevant medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards. Lead internal and external audits as required.
- Provide ongoing coaching, training, and development opportunities for the quality team. Create individualised development plans to help team members grow in their careers and enhance their skill sets.
- Collaborate closely with other departments, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated into all aspects of product development and production.
- Identify areas for process improvement within the QMS and across the organisation. Implement best practices to enhance product quality, reduce risk, and increase efficiency.
Qualifications:
- Minimum of 5 years of experience in quality management within the medical device industry.
- Strong knowledge of QMS implementation and management, including ISO 13485 and FDA regulations.
- Proven experience in leading and managing a team, with a passion for coaching and developing others.
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