Quality Assurance Manager

2 weeks ago


bedfordshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time
Quality Manager - Medical Devices

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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