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 / firstname.lastname@example.org
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