Quality Assurance Manager

3 days ago

Bedford, Bedford, United Kingdom Cure Talent Full time
Job Opportunity

Cure Talent is partnering with a leading global medical diagnostics and IVD products company to fill a key role in their organization.

We are seeking an experienced Quality Systems Manager to join their highly motivated team. The successful candidate will be responsible for leading and managing the quality systems team, ensuring the effectiveness of the Quality Management System (QMS), and maintaining compliance across the design, development, manufacture, and distribution of in-vitro diagnostic medical devices.

The ideal candidate will have strong experience managing quality and compliance in a medical device environment, with knowledge of compliance management throughout the full design control lifecycle under ISO 13485 and US FDA 21 CFR Part 820.

Key responsibilities will include:

  • Leading and managing the quality systems team to ensure effective QMS implementation and compliance.
  • Developing and implementing quality policies, procedures, and processes to ensure compliance with regulatory requirements.
  • Conducting audits and assessments to identify areas for improvement and implementing corrective actions.
  • Collaborating with cross-functional teams to ensure quality and compliance are integrated into all aspects of the business.
  • Providing training and guidance to employees on quality and compliance procedures and policies.

The successful candidate will have a track record of improving established Quality Management Systems and proven leadership and people management skills, with the ability to inspire and influence key stakeholders at all levels.

This is an exciting opportunity to join a company that is passionate about people and innovation in healthcare, and to make a positive impact on the organization.

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