Quality Manager


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Job Ref: J22230
Sector: Science
Sub-sector: Medical Devices
Date Added: 22 June 2017

Job Title: Quality ManagerVacancy type: PermanentArea: EssexCompetitive salary & benefits packageSRG is working with an expanding medical device company who as a result of their continued success are currently looking to make a senior appointment within their Global Quality team. Reporting to the Technical Director, this role will involve the management of day to day quality and compliance functions of the business to provide outstanding service and products. The role:To support the technical director in planning and developing strategy of the company, in relation to QMS and regulatory considerations, providing input in all aspects including NPD and export markets.To implement the smooth and effective management of the Quality Management System; to agree the level of resource required to run the Quality team, and to manage the department with these levels. Provide technical and quality leadership to enable the determination and implementation of priorities, in order that critical deadlines are met. Management of compliance with all applicable regulations including but not limited to MDD 93/42/EEC and US FDA 21 820 QSR.Maintain conformance to ISO9001 and ISO 13485 standards.Management of the internal audit system in addition to hosting client/3rd party audits where necessary.Ensuring appropriate investigation of discrepancies, non-conformances, complaints, failures and escalation to corrective and preventive action (CAPA) ensuring all incidents are properly investigated, documented and actioned within the Quality Management System and company timelines. Acting as main point of contact for national competent authorities and notified bodies.Report on all quality activities to leadership and stakeholders.The ideal candidate should be educated to degree level or equivalent and should have a demonstrable equivalent experience as follows:Experience of manufacturing in a regulated environment (preferably ISO 13485).Extensive and in depth knowledge of medical device regulations (both EU and Global).Experience in setting up or developing a QMS.Experienced auditor, QMS and supplier.Experience of submission of documents and reports including technical dossiers, MDRS, 510K and CE marking submissions.Experience in ISO re-certification would also be desirable.This is an exciting opportunity for a Quality Manager to be part of an expanding company and contribute to further development and expansion. If you are interested in this role, please email your CV . If you want more information regarding this role, feel free to contact Amie on 01223 235 203.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.