Senior Quality Specialist, Kent, £35-40k, Medical Devices, IVDs

Recruiter
Meet
Location
East Horsley
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Quality Specialist, Kent, £35-40k, Medical Devices, 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: Ensure compliance to external (regulatory) requirements, including Quality Management Systems: ISO 13485, Quality Systems Regulation, MDR/IVDR). Maintain compliance to the requirements of site’s Quality System and ensuring the Quality Assurance team meets the QMS objectives for the site. Responsible for reviewing and approving quality documents in line with local quality procedures. Undertake QA responsibilities regarding failure investigations, hold and recall investigations, risk assessments and field actions, ensuring all necessary review are timely documented and completed. Perform internal audit to ensure compliance to external regulatory requirements. Assist with mentoring and leading a small team of Quality Assurance professionals. Lead in the role of Risk Management and PMS; with knowledge of ISO14971. Deputise for the Quality Manager in their absence. Skills preferred: Experience within medical devices; ISO 13485 Experience with rick management; ISO 14971 Post Market Surveillance Continuous Improvement 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 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, Kent, Graves End, Grays, Dartford, Rochester, Maidstone

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