Quality Management System Supervisor, Basingstoke, £DOE, IVDs

Recruiter
Meet
Location
All Saints
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
QMS Supervisor, Basingstoke, £DOE, IVDs 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. General Responsibilities: Prepare the annual audit plans and carry out internal and external quality audits to ensure compliance with ISO 13485, ISO 9001, FDA 21 CFR 820 and the European IVD Directive. Organize and host customer audits. Coorindate and minute site management review meetings. Ensure that product quality is maintained throughout the manufacturing process by quality audit / assessment and implementation of recommended quality improvements. Provide Quality input to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs. Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs. Provide QA oversight of CSV activities pertaining to e-QMS applications. Skills preferred: Medical device (ISO 13485, 21 CFR 820), or GMP (21 CFR 820, 210, 211) background. Experience in auditing practices and principles; formal internal and external auditor training required. Demonstrated working knowledge of compliance, quality and scientific principles. Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma / PPI. 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, 13485, MDR, IDVR, Quality Engineer, Senior Quality Associate, Quality Assurance, Quality Management System Supervisor, QMS Supervisor, 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, Medical Device, South East England, South East, Basingstoke, Reading, Winchester, Andover, Farnborough, Guilford

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