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Vacancy Details


R&D Quality Engineer - 12 month contract - Clare

Contract Type: Temporary
Location: Clare
Date: 17/10/2018
Job Reference: 96100

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

R&D Quality Engineer
Our client, a medical device company in Clare is currently looking to recruit a R&D Quality Engineer for their site.

Include but are not limited to the following:
  • Responsible for the support of the Design Control Process, including design change, within all areas in the company
  • Act as quality representative on design projects
  • Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs)
  • Support R&D, System integration, Packaging Development and Customer Support from a QA perspective.
  • Aid in updating all Design Control and R&D procedures/systems, as well as above mentioned departments, to ensure compliance with regulations and BC global procedures
  • Conduct internal audits to ensure compliance of R&D and other technical areas as appropriate (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements
  • Provides informal guidance to new team members
  • May act as a Risk Management Specialist
  • May act as an FMEA facilitator
  • Completion of Post Market Surveillance reports
  • Duties as prescribed by the company R & D Quality Team Lead or R&D Quality Manager

Education & Experience:
  • Will hold a B.Sc. or M.Sc. in chemistry, biochemistry, biology or other relevant technical field
  • Minimum of 2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment.
  • Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management
  • Excellent interpersonal / communication skills
  • Strong team member with the ability to identify and drive quality improvements
  • Excellent Planning and organisational skills

For further information on this R&D Quality Engineer role in Clare please contact Bimi Felix on 086 8395533 /

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