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R&D Quality Engineer

Expired
  • Salary: Negotiable
  • Job type: Contract
  • Location: Clare
  • Sector: Science
  • Date posted: 30/05/2018
  • Job reference: J387248A

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R&D Quality Engineer

A R&D Quality Engineer is required to join a leading Med Device company based in the South West. This position offers an impressive and unique opportunity for interested candidates and requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Med Device industry in Ireland.

Responsibilities

Include but are not limited to the following:

  • Responsible for the support of the Design Control Process, including design change, within all areas in BCII
  • 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 BCII R & D Quality Team Lead or R&D Quality Manager

Qualifications

  • 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.

Education & Experience

  • 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

Interested?

For more information do not hesitate to reach out to Jack on 01-6455262, or email jack.conway-kenny AT experis.ie

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