Fantastic opportunity for a Quality Manager to join our medical device client in Northamptonshire on a 6 month Fixed Term Contract. Applicants should be experienced with ISO 13485, validation and verification and MDR would be advantageous.
Client Details
Our client are a regulated manufacturing and distribution company based in the Northampton area. They are going through a period of growth and development and are currently looking for a Quality Manager to join their team on a 6 Month FTC. The role is suitable for someone looking for a step into management.
Description
Key Responsibilities but not limited to:
- Creation and control of quality documents (SOPs, WIs, records etc)
- Management Representative responsible for ISO 14385 certification and maintaining the effectiveness of the Full Support Healthcare QMS
- Maintenance and communication where required of technical documentation
- Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframes
- Validation of sterilisation and packaging processes
- Arrange required product testing and review test reports
- Validation of sterilisation and packaging processes
- Completing QC inspections and checking samples as required
- Notified / Approved Body Audits & other External Audits
- Manage Internal audit programme
- Monitoring of subcontracted processes including measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised
- Verification and Validation of new products and product range extensions.
Profile
- 5+ years' experience in a healthcare quality and regulatory compliance role.
- ISO 13485 auditor.
- Working knowledge of ISO 13485, UK and EU MDR.
- Demonstrable technical writing capability.
- Excellent attention to detail.
- Interpersonal and communications skills, both verbal and written.
- Knowledge and practical experience with analytical/statistical techniques.
- Proven planning/organisational skills, ability to handle multiple projects simultaneously with the ability to meet tight timescales/deadlines. Must be adaptable, numerate, literate and be willing and quick to learn with the desire to succeed
- Knowledge and practical experience of using QMS software (Q-Pulse desirable).
Job Offer
- Highly negotiable basic salary.
- Other benefits.
- Please contact Natalie Hudson at Michael Page Birmingham.