Medical Device Quality Inspector


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

1st September 2021

Location

Dublin City Centre

Salary/Rate

£45180 - £58734

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

Job title: Medical Devices Quality InspectorLocation: Dublin city centre, must be willing to travel around Ireland.Benefits: Salary, pension, healthcare and an amazing career opportunity. SUMMARY:Reporting to the Medical Device Inspection Operations Manager, the Medical Devices Inspector will be primarily responsible for:Planning and conducting proactive and reactive inspections of manufacturersExecution of inspections relating to designation of notified bodies for medical devices in Ireland.Execution of inspections and ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies.The role of a Medical Device Inspector is to identify and evaluate issues at sites inspected, nationally and internationally, that may result in; Medical devices being placed on the market that are non-compliant with the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards and other relevant guidance.notified bodies, economic operators and other entities that are non-compliant with their obligations and the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards and relevant guidance.The sites to be inspected, nationally and internationally, may include;Manufacturers of medical devicesAuthorised RepresentativesContract Sterilisation sitesNotified BodiesDistributors & importers of medical devicesCritical suppliers and subcontractors of medical device manufacturers KEY RESPONSIBILITIES: Strategic ObjectivesSupporting the Medical Device Inspection Operations Manager to ensure our regulatory activities are centred on scientific & regulatory excellence, are value-driven and optimised to achieve the highest standards of device safety, performance and care for patients and healthcare systems.Working with the Medical Device Inspection Operations Manager to prioritise work objectives and to ensure that the strategic goals and targets of the Medical Devices Department are achieved.Contributing to the formulation and preparation of national / international regulatory policies, guidelines and legislation as deemed appropriate.Operational Objectives Prepare for, organise and carry out inspections, nationally and internationally, in accordance with procedures.Ensure appropriate preparation and follow up on inspection activities and other related market surveillance activities are completed.Coordinate with relevant teams across the Department in the preparation, conduct and follow up from the inspection.Quality and Knowledge Management Assist the Medical Device Inspection Operations Manager and the managers of the Assessment & Surveillance section to ensure:The effective implementation of the HPRA Quality Management SystemThat there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gainedThat information and knowledge available across the HPRA is effectively usedThat inspection procedures remain up to date with relevant developments QUALIFICATIONS AND EXPERIENCE REQUIRED:A 3rd level degree in an engineering or other relevant scientific disciplineAuditing/Inspection experience in medical devices/technology or related healthcare industry with a strong working knowledge of the regulatory environment and relevant quality standardA full driving licenceAvailability to travel for national and international inspections is a requirement in this role. If you are interested in seeing the full job spec and discussing further forward your up to date CV or contact me via the details provided and we can organise a call to discuss further. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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