Our client is a well-known Medical Device company that has been established for over 50 years. This family run business has gone from strength to strength and is now continuing to grow in both product portfolio and turnover.
Responsible for the day to day management of operational processes and documentation in relation to the Quality Management System. The successful candidate will maintain effectiveness and compliance in the Quality Management System and will be able to audit to ISO13485 in order to maintain accreditation.
- Organising and managing the external ISO 9001/ISO13485 quality system audit/s on an annual basis to ensure continual accreditation.
- Ensure that document control procedures are adopted to approve, review and update all changes to critical documents within the scope of the QMS
- Ensure that records are established and maintained to provide evidence that the QMS is being followed.
- Ensure that the QMS is reviewed at planned intervals to ensure its continued suitability, adequacy and effectiveness.
- Ensure that regular assessments of customer satisfaction are taken and that improvements are identified and implemented.
- Ensure that an internal audit programme is adopted and managed to ensure that the QMS system conforms to planned arrangements.
- To act as official representative in relationship to ISO 13485, CE marking and Canadian Medical Devices Regulations, including informing the relevant notified body of any significant changes to the quality system.
- Ensuring that the control of documents and data is properly exercised as required by the approved procedure.
- Managing the Change Note and design changes systems
- Ensuring that traceability of components and devices can be effected
- Arranging that all relevant customer complaints are actioned as applicable and that the fault/recall system works when necessary
- Experience working on or to: ISO9001, ISO13485, CE Marking and Medical Device Directive
- Experience in gaining regulatory approval for Medical Devices all over the world
- Understand the Product Development cycle and have had input into the R&D process
- Experience in moving an organisation towards Total Quality Management
Contact: Adrian Hole
Keywords: ISO13485, quality, quality manager, audit, regulatory, FDA, medical device, audit, lead auditor
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