Quality Assurance Manager

4 days ago


Bedfordshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time
Job Title: Quality Manager - Medical Devices

About the Role:

We are seeking a highly motivated and experienced Quality Manager to lead our team of quality professionals in the medical device industry. As a key member of our organization, you will be responsible for overseeing and enhancing our Quality Management System (QMS) to ensure top-tier compliance and continuous improvement.

Key Responsibilities:

  • Lead and motivate a team of five quality professionals with varying levels of experience.
  • Take ownership of the newly implemented Quality Management System (QMS), ensuring it meets regulatory requirements and aligns with company standards.
  • Ensure compliance with all relevant medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
  • Provide ongoing coaching, training, and development opportunities for the quality team.
  • Create individualized 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.
  • Implement best practices to enhance product quality, reduce risk, and increase efficiency.

Requirements:

  • 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 development.


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