Design Assurance Engineer Job in Galway, Ireland

Collins McNicholas is an Irish based recruitment agency which has over two decades of experience in recruiting at all levels for an extensive client base.

With five offices in Dublin, Cork, Galway, Sligo and Athlone, Collins McNicholas is a nationwide recruiter for permanent, temp and contract staff for our client base of multi-nationals, SME's, Indigenous companies and Public Sector clients.

Design Assurance Engineer Job Description

Our client, a global leader in its field currently has a requirement for a Design Assurance Engineer based in Galway, Ireland.

Responsibilities

• Provide technical leadership for all Quality deliverables defined by the PDP.
• Support creation of design controls (e.g. specification setting and justification, process instruction creation, receiving inspection).
• Lead and manage extended QA team members and ensure that all QA activities in support of PDP are completed per plan and in accordance with procedures.
• Participate in and co-ordinate the evaluation of new products, assuring the safety and efficacy of the devices.
• Prepare / critically review design verification and shelf life protocols / reports.
• Support overall quality function planning / activities within PDP.
• Define and agree with functional stake holders the project needs for Quality and the specific approaches required to meet them.
• Provide expert 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, transfer and commercialization activities.
• Adhere to Quality System and Design Control requirements.
• Support (input and critical review) of regulatory submissions. May author sections of submissions.

Design Assurance Engineer Job Requirements

• Bachelor’s Degree in Engineering or Science related Discipline (Master’s Degree desirable)
• Excellent verbal and written communication skills are essential for this role, together with an ability to be self directed and to effectively interface with various levels and functions within the organization.
• Minimum of 5 years experience, with at least 3 years experience in the Medical Device industry.

Design Assurance Engineer Application Information

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Design Assurance Engineer Summary

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