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 firstname.lastname@example.org, quoting job ref 49602
It is essential that applicants hold entitlement to work in the UK.