Quality Manager (Operations) Motherwell

CK Science are recruiting for a Quality Manager for a rapidly growing research and development company at their site based near Glasgow.

The Company: Our client is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions.

Quality Manager Role: You will report to the Quality Director (Operations) and the role is responsible for all Operational Quality requirements, ensuring compliance at a site level to the QMS and accountability for compliant release of product.

Your main duties will be to:

• Demonstrate and lead a quality compliance culture setting the required quality standards for product and processes as well as identifying and driving continuous improvement to local quality systems / processes
• Manage the site QMS processes and infrastructure to ensure continued compliance and fitness for purpose.
• Communicate and coordinate significant quality issues including completing impact assessments and decisions on product disposition.
• Manage and host external audits for global certification purposes.

Your Background: The ideal candidate for this role will have:

• Educated to degree level or above in life science or a related field with experience of working in an IVD or medical device environment or similar at Quality Manager level.
• Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
• Experience of managing and hosting competent authority, notified body and customer audits.
• Experience of managing and developing a high performing team

For more information or to apply for this Quality Manager position, please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk, quoting job ref 49602

It is essential that applicants hold entitlement to work in the UK.