Senior Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Design Assurance Engineer for their site.
- You will support both New Product Development & sustaining commercial projects from a Design Assurance perspective.
- You will be responsible for defining and agreeing with functional stakeholders the project needs for Quality and the specific approaches required to meet.
- You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering / extended QA team.
- You will be leading root cause investigations; drive problem solving efforts for quality issues and encourage and promote DRM principles.
- You will support risk management activities, quality function planning / activities within PDP, regulatory submissions and support customer complaint analysis and post market surveillance activities.
- You will participate in 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.
- You will understand roles and responsibilities of extended quality functions that support the PDP process.
- You will input constructively into Test Method development/validation and adhere to Quality System and Design Control requirements.
- You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities.
- You will generate and approve change requests.
- We are looking for a qualified person to Level 8 Degree in Engineering / Science or related technical discipline and desirably with 5 years work experience, with at least 3 years in a comparable role.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced with an ability to be self-directed and to effectively interface with various levels and functions within the organization.
- Ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable.
- This role will involve some travel.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Design Assurance Engineer role in Galway please contact Bimi Felix on 0868395533 / email@example.com
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