Quality Assurance Manager, Cambridgeshire, £50-60k, IVDs

Recruiter
Meet
Location
Bedfordshire
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
QA Manager, IVDs, Cambridge, £50-60k Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential. Overview of Key Duties and Responsibilities Achieve and maintain ISO13485 certification for the organisation. Support the Product Development Group and provide input in the Product Development Process where required from a Quality and Regulatory perspective and in the creation of technical files. Maintain the quality management system. Manage the day to day aspect of document control and issuance of training records related to QA, manage the training matrix reflecting and identify gaps in training per operator role. Work with team leaders to advise on required training and deliver training on quality SOPs. Conduct spot checks and internal quality audits regularly and in a supportive constructive manner, coordinate a review of the results and ensure corrective actions are agreed and implemented in the timescales set. Key Skill Required: Quality experience within the IVD industry At least 3 years’ experience within an ISO 13485 environment Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical file Experience in product development and creating design history files Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential. Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way. Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/ Key Words Medical Devices, IVD, Diagnostic, Senior Quality Associate, Quality Assurance, Quality Assurance Officer Jobs, Medical Device Jobs, QA Associate, QA/RA Associate, Quality Assurance Associate Jobs, Quality Assurance Associate, Quality Assurance Officer, Quality Assurance Manager, Quality Assurance/Regulatory Affairs Manager, QA/RA Manager, Medical Device, Cambridge, Luton, Ely, Northampton, Bedford, Milton Keynes

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