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SRG Engineering
,
Gloucester, Gloucestershire
Quality Manager
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Salary: £60000 - £100000 per annum |
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Overview
Quality Manager - Medical Technology - Cambridgeshire - £60,000 - £100,000 per annum Share Options SRG are currently recruiting for a Quality Manager to join a start-up Medical Technology company based in Cambridgeshire on a full-time, permanent basis at a competitive remuneration package, depending on experience along with share options. The Role: This is a full-time role based at the company's Cambridge facility to work directly alongside the Chief Development Officer as the company takes its first product through industrialisation and clinical trials. You will understand and have oversight of In Vitro Diagnostics within the Quality systems and be developing and maintaining a compliant Quality Management system that is 'fit for purpose' and adapts to changing business needs. Awareness of Regulation (EU) 2017/746 Key Responsibilities Helping to define and populate the company's quality procedures in line with both ISO 13485 and 21 CFR part 820 alongside the internal team and external quality and regulatory consultants and ensure those processes needed for the electronic quality management system (eQMS) are established, implemented and maintained. Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to standards, practices and regulations Research and input to key technical documents including analysis of relevant standards, creation and review of product specifications, verification and validation plans etc Report to senior management through management review on the performance of the quality management system and any need for improvement using KPIs Perform and executes audits in compliance with ISO 13485, CFR 820.0 and IVDR as applicable Management of the internal audit program. Supporting and carrying out risk management activities in line with ISO 14971 Supporting the setup of internal facilities and capabilities from a quality and regulatory standpoint Provide Quality and Regulatory expertise to product development core teams to support the design and development teams with guidance relating to compliance activities Liaise with external suppliers, contract manufacturing partners and corporate partners on issues relating to quality and regulatory affairs It is intended that as the company grows the quality and regulatory affairs team will grow under the management of the preferred candidate but in the immediate term it is expected the candidate will be able to fulfil a number of roles as is typical in small company environments. For more information, please call Laith Mustafa on 0161 868 2231 or email