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Senior Quality Engineer - Post Market, Cork
Client:
CareerWise Recruitment
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
f1bcf0a97852
Job Views:
4
Posted:
09.08.2025
Expiry Date:
23.09.2025
Job Description:
Job Description
A SENIOR QUALITY ENGINEER is required by CareerWise Recruitment for our multinational medical device client in Galway for a hybrid role on an initial 12-month contract.
The SENIOR QUALITY ENGINEER will support a Post Market team and be directly involved in ensuring the products are maintained throughout the full product lifecycle. This includes the introduction and implementation of product, process, and materials changes to manufacturing operations.
Role of this position
Assess patient risk appropriately for design changes.
Provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Manufacturing Engineering.
Generate Design Verification protocols and participate in the compilation of design verification and shelf-life data for regulatory submissions to support design change approval.
Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
Establish strong cross-functional relationships across the organization and with partners within a complex technical environment.
Generate and approve change requests.
Lead investigation analysis and ensure timely completion.
Job Requirements
Bachelor's Degree (Level 8) in Engineering, Science, or related discipline.
4+ years of experience in a design assurance, R&D, or Quality role within the Medical Device industry.
Strong critical thinking and problem-solving skills.
Ability to collaborate effectively within a talented team and work proactively on cross-functional teams.
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