Our client a major multinational here in Galway are looking to hire a Senior Design Assurance Quality Engineer on an initial 12-month fixed term contract.
The Role: As the Senior Quality Engineer you will play a critical part in ensuring that medical device products continue to meet the highest quality and regulatory standards throughout the full product lifecycle.
Responsibilities: Support sustaining engineering projects by providing Design Assurance expertise to ensure compliance with global regulatory and quality standards.Evaluate and support the implementation of product, process, and material changes within manufacturing operations.
Perform patient risk assessments related to proposed design changes.Provide Quality Assurance direction and technical input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering teams.Generate and manage Design Verification protocols, and participate in the compilation and review of verification and shelf life data for regulatory submissions.Partner with Regulatory Affairs to ensure clear, accurate, and complete information is presented in submissions to minimize regulatory queries.Establish and maintain strong cross-functional relationships across R&D, Manufacturing, Regulatory, and other stakeholders in a complex technical environment.Stay current with evolving regulatory compliance requirements related to product design, development, and commercialization, and apply this knowledge to projects and initiatives.Generate and approve change requests in accordance with internal and external requirements.Lead investigation activities, root cause analysis, and timely resolution of quality issues related to design or process.Collaborate with engineering and manufacturing teams to ensure robust quality standards are implemented and maintained.Design or specify inspection and test methods, equipment, and quality assurance procedures.
Conduct QA testing and statistical analysis as required.Ensure that corrective and preventive actions (CAPA) are implemented effectively and documented in accordance with regulatory and quality standards.May specialize in one or more quality disciplines including design, incoming inspection, production control, product evaluation, reliability, inventory control, or R&D quality support.Qualifications: Bachelor's degree in Engineering, Science, or a related technical field.Minimum of 5 years' experience in a Quality Assurance or Design Assurance role within the medical device industry.In-depth knowledge of ISO 13485, 21 CFR Part 820, and other applicable global medical device regulations and standards.Demonstrated experience with design control, risk management (ISO 14971), validation/qualification activities, and root cause analysis.Strong written and verbal communication skills; experience interfacing with regulatory bodies is a plus.Proficient in statistical tools and quality methodologies (e.g., Six Sigma, CAPA, FMEA).Ability to manage multiple priorities and work effectively in a collaborative, fast-paced environment.For more information and a confidential discussion on the role please contactAmy Newell. ****** 091 706718
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