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Director of Quality Assurance

2 months ago

Cambridgeshire and Peterborough, United Kingdom CV Library Full time
Job Title: Director of Quality Assurance

Location: Bedfordshire

We are seeking a highly motivated and experienced Director of Quality Assurance to lead our quality management team and drive excellence in our medical device industry.

The successful candidate will have a strong background in quality management, with a proven track record of implementing and managing Quality Management Systems (QMS) that meet regulatory requirements and align with company standards.

Key Responsibilities:

  1. Lead and Motivate a Team: Lead, mentor, and motivate a team of quality professionals with varying levels of experience.
  2. Quality Management System (QMS) Ownership: Take ownership of the newly implemented QMS, ensuring it meets regulatory requirements and aligns with company standards.
  3. Compliance and Regulatory Affairs: Ensure compliance with all relevant medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
  4. Coaching and Development: 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.
  5. Collaboration and Integration: 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.

Qualifications:

  1. Experience: Minimum of 5 years of experience in quality management within the medical device industry.
  2. Knowledge: Strong knowledge of QMS implementation and management, including ISO 13485 and FDA regulations.
  3. Leadership: Proven experience in leading and managing a team, with a passion for coaching.