CK Group are recruiting for a Quality Manager on behalf of a growing and award winning Medical Device manufacturer to be based at their site in Hartlepool on a permanent basis.
Reporting to the Managing Director, this is a hands-on role where youwill be working as part of a team to ensure quality and regulatory standards are met for their innovative range of products.
Your role is concerned with monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards. Using your knowledge of ISO 13485, you will be expected to collaborate closely with your colleagues to assist with Quality and Regulatory activities to maintain an appropriate quality environment.
The role and responsibilities:
- Manage day to day activities of the Quality Assurance and Quality Control departments and be the senior QA contact for all company activity.
- Be responsible for all quality assurance activities, e.g. GxP (Good laboratory, clinical, manufacturing, distribution and documentation practices), company SOPs and policies, QA validation activities and compliance training.
- Oversee QA for all GMP activity including batch record review and batch release, to ensure that controlled documents are followed, standards of quality are maintained, and documentation is complete.
Experience and Qualifications: The ideal candidate should:
- Be educated to degree level, or have equivalent experience
- Haveexperience in the development and implementation of quality procedures and specifications.
- Have experience of process validation, root cause analysis, NCR’s and internal and external audits.
- Have experience of working in a highly regulated (i.e Medical Device, Diagnostics or Pharmaceutical) environment
Our client are offering a competitive salary alongside a number of additional perks. The company operates a flexible working hours scheme with on-site access between 7:00 and 19:00, core hours between 10:00 and 15:00, home working is possible as far as your duties allow it. You would be eligible for an employee health insurance scheme and enhanced holiday entitlement. The organisation strive to offer all employees excellent CPDopportunities so they would encourage you to attend conferences and join regional and national networks.
For further information, or to apply for the position, please contact Sarah Farrow on 0191 3706486 or email@example.com