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Senior Design Assurance Engineer

Job Title: Senior Design Assurance Engineer
Contract Type: Permanent
Location: Galway
REF: 90941
Job Published: 11 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

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.
Our Offer
  • 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.
Your Profile
  • 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 086 8395533 /
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