Design Assurance Engineer
Our client, a medical device company who recently set up in Galway requires an experienced DA Engineer for a job.
- Support risk management activities.
- Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project eam environment providing technical and Quality systems input to the team.
- ?Prepare / critically review design verification/validation and shelf life protocols / reports.
- Support overall quality function planning / activities within PDP.
- Provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering / extended QA team.
- Maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design development, and transfer and commercialization activities.
- Support of regulatory submissions. May author sections of submissions.
- Lead or support root cause investigations; drive problem solving efforts for quality issues.
- Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release. Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
- Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
Education, Experience and Skills
- Min of a Bachelor?s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science).
- 3 years working experience in a comparable role. Proven ability to work well as part of a team & on own with minimum supervision
- Good team member, fully motivated to achieve and demonstrate best practices in line with the project, department and site objective.
For further information please contact Cliona O?Malley on 091730022 /
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