Quality and Reg manager
Northamptonshire
up to £60,000 (based on 12 months salary)
6 month FTC
CPL have teamed up with a company who specialises in supplying market leading Respiratory Protective medical devices to the Healthcare sector. They now have an exciting opportunity for an experienced Quality and regulatory manager to join their organisation based in Northamptonshire on a 6 month Fixed term contract.
About the Role:
- Creating and controlling of quality documents
- Management Representative responsible for ISO13485 certification and maintaining the effectiveness of the Full Support Healthcare QMS
- Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframes
- The Validation of sterilisation and packaging processes
- Completing QC inspections and checking samples
- Notified / Approved Body Audits & other External Audits
- Manage Internal audit programme.
KEY Experience
- 5+ years' experience in a healthcare quality and reg compliance role
- ISO 13485 auditor
- Working knowledge of ISO13485, UK and EU MDR
- Great Communications skills, both verbal and written
- Ability to handle multiple projects simultaneously
- Knowledge and practical experience of using QMS software (Q-Pulse desirable)
Please note in order for your application to be successful you must hold a valid right to work document for the UK as no sponsorship is offered.
To apply for this role please send your CV through to for more information