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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 supporting a Post Market team and be directly involved in making sure the products are maintained through the full product lifecycle. This will also include the introduction/implementation of product/process/materials changes to the manufacturing operation.
Role of this position
* You will assess the patient risk appropriately for these design changes.
* You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
* Responsible for generation of Design Verification protocols & will 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.
* Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
* You will generate and approve change requests.
* Lead investigation analysis and timely completion of same
JOB REQUIREMENTS
* Bachelors Degree (Level 8) in Engineering, Science, or related discipline.
* 4+ years’ experience in a design assurance/R&D/Quality role within the Medical Device industry
* Strong critical thinking and problem-solving ability
* Ability to collaborate effectively within a talented team and can work effectively and proactively on cross-functional teams.
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