QA RA Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

30th September 2019

Location

Galway

Salary/Rate

£54 - £63

Type

Contract

Start Date

ASAP

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

The company are a globally recognised medical device company, specialising in the manufacture of a number of medical devices. Role: Quality and Regulatory ManagerContract: An initial 3 month hourly rate contractLocation: Galway Your role as a Quality and Regulatory Manager will be to develop and maintain quality systems related to the development and manufacture of guide wires. Responsibilities:Develop and lead a strong quality team to ISO13485 standards.Supervision of Quality Engineers to ensure compliance for areas of responsibility for: process controls, supplier performance, assuring product quality and qualification and validation.Be an active member of the management team and work with all staff to develop a world - class lean manufacturing process.Ensue regulatory compliance of new products, prior to market release.Ensure compliance with DMR.Provide Quality Engineering support for: technical queries relating to compliance, and updating related FMEAs as required.Develop and maintain a program ensuring only correctly validated equipment is used in production processes.Prepare validations, verification's, risk analysis and other product assurance activities, ensuring test method validations are in place.Responsible for the organisation, training and direct supervision of Quality Engineers and Inspectors. Requirements:Degree in Science / Engineering disciplines.Qualified Lead auditor for ISO13485.5+ years experience within the medical device industry.Experience with USA regulatory requirements would be advantageous.Strong communication skills.Excellent attention to detail.Working knowledge of Excel and Word. This is an excellent opportunity to work as part of a globally recognised medical device company in Galway, as part of an innovative engineering team. No CV ready? Not sure yet? Feel free to contact me for further details on this exciting opportunity! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business 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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