|Role Type||Fixed Term Contract|
Senior R&D Quality Engineer
Senior R&D / Design Assurance Engineer
My MNC Diagnostics Client in Co. Clare are searching for a Senior Design Assurance Engineer with five years of relevant experience in DA and risk management working with R&D, to join their team on a 18 Month FTC basis. This is a client that has seen so much growth over the last few years and look forward to welcoming new team members! This role is an initial 18 month contract with the possibility of extension.
- Act as quality representative on Design Change Projects and Innovation DP 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.
- Responsible for the support of the Design Control Process, including design change, within all areas.
- Review and approve validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final validation reports ensuring compliance to all applicable procedures, work instructions and standards.
- Solves complex problems and exercises judgement on the analysis of multiple sources of information.
- 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.
- Assist colleagues with less experience and provides training to staff on the specific requirements of the Design Control process in BCII and regulatory or standard requirements.
- As required 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.
- May act as a Risk Management Specialist.
- May act as a FMEA facilitator.
- Completion of Post Market Surveillance reports.
Education & Experience:
- Bachelor’s degree qualified
- 5 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.
For further information on this Senior R&D Quality Engineer role in Clare please contact Marchon Monroe on 086 044 9473 / email@example.com
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