Senior Quality Engineer

3 weeks ago

Galway, Galway, Ireland Sigmar Recruitment Full time

About Your New Employer Join a global leader on a Senior quality engineer contract in the medical technology industry. This will be a 12-month contract based in Galway. You will be supporting new projects through change of materials and processes. You will be the point of contact communicating with cross-functional teams regarding the project. About Your New Job as a Senior Quality Engineer Support the sustainability of commercial projects from a Design Assurance perspective, ensuring products comply with global standards throughout their lifecycle. Facilitate the introduction and implementation of product, process, and material changes in manufacturing, assessing patient risk for design changes. Provide QA technical direction and input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering. Develop Design Verification protocols and contribute to the compilation of design verification and shelf life data for regulatory submissions. Interface with Regulatory Affairs to ensure clear presentation of information, minimizing Regulatory Agency queries. Establish strong cross-functional relationships within the organization and with external partners in a complex technical environment. Maintain up-to-date knowledge of regulatory compliance requirements for product design, development, and commercialization. Generate and approve change requests, lead investigation analyses, and ensure timely completion. Collaborate with engineering and manufacturing functions to ensure quality standards are upheld. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess product/material compliance. Ensure corrective measures meet acceptable reliability standards and that documentation complies with requirements. Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or R&D as they apply to product/process quality. Collaborate with the complaints team for complex investigations. Understand and apply risk management concepts to meet FDA, ANSI/AAMI/ISO , and ANSI/AAMI/ISO requirements. What Skills You Need as a Senior Quality Engineer Bachelor Degree (Level 8) in Engineering or similar discipline 5 years experience working in a similar role ideally with design assurance experience Strong knowledge of regulatory compliance requirements for product design, development, and commercialization. Excellent cross-functional collaboration skills. Ability to generate and approve change requests and lead investigation analysis. Proficiency in designing or specifying inspection and testing mechanisms and equipment. Understanding of risk management concepts and compliance with FDA, ANSI/AAMI/ISO standards. Whats on Offer as a Senior Quality Engineer Rate up to €35 per hour. Hybrid work environment offering flexibility. Collaborative and innovative work culture. Whats Next Apply now by clicking the Apply Now" button or call me, Elaine McCarthy, on or . If the job isnt quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available. Skills: CAPA design assurance Investigations medical device risk management Benefits: See Description

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