Quality Manager / Fixed Term Contract / 12 Months / Quality Assurance / ISO 13485 / Quality / QA

This job has now expired please search on the home page to find live IT Jobs.

Location: OxfordshireSalary: £30,000 - £35,000 per annumJob Title: Quality Manager (12 Month Fixed Term Contract)Position Summary:The position of Quality Manager - Maternity Cover is responsible for managing and co-ordinating Quality Management System activities related to the company and other applicable company development projects.The Quality Manager - Maternity Cover will report directly to the Director of Quality and Regulatory Affairs.The Quality Manager - Maternity Cover is for 12 months.Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive and the person will be expected to complete tasks reasonably requested by the Director of Quality and Regulatory Affairs. Major Responsibilities

'€¢Under direction from the Director of Quality and Regulatory Affairs, the Quality Manager will:'€¢Supervision of the Company's Quality Management System (QMS)'€¢Working with the Director of Quality and Regulatory Affairs manage the company's QMS to ISO 13485:2016, including CMDCAS'€¢Working with the Director of Quality and Regulatory Affairs manage the company's QMS to US QSR 21 CFR part 820'€¢Maintaining and updating the changes to the company's Quality Manual'€¢Ensuring that all Standard Operating Procedures and work instructions are current, up to date and implemented'€¢Ensure controlled copies of QMS documentation are maintained'€¢Ensuring that all company employees are trained in the use of the company's QMS, ensuring compliance and maintenance of training records'€¢Perform key supplier audits and maintain the audit schedule'€¢Work with suppliers to ensure close out and resolution of any CAs arising from supplier audits'€¢Work closely with and support Suppliers in the event of any NCs or issues'€¢Maintain supplier approval records'€¢Working with the Director of Quality and Regulatory Affairs, ensure all internal audits are performed to schedule and ensure timely resolution of any NCs raised'€¢Ensure all design changes are fully documented and approved'€¢Review and approve Product for final release'€¢Maintenance of Device History Records post release'€¢Review and approve servicing activities'€¢Ensure Device Master Records including product labelling are current, up to date and implemented'€¢Maintain Non-Conformance and CAPA processes ensuring reports are closed out within specified time frame'€¢Assist the Director of Quality

If this is something that you think either you or someone you know would be suited to and interested in, then please do get in touch by applying online and calling Jack Lundgren on 0207 812 7700.Key Skills: Quality Manager / Fixed Term Contract / 12 Months / Quality Assurance / ISO 13485 / Quality / QA / Internal Auditing / CAPA / Document Control / Non-Conformances