Quality Engineer II About Your New Employer Join a global leader in medical device in Galway.
We are looking for an Quality Engineer II to join on a 12-month contract.
You will be part of a dynamic and supportive team that values innovation and excellence.
As a Quality Engineer II, you'll play a pivotal role in supporting the development and implementation of quality systems.
You'll collaborate closely with internal teams and manufacturing partners during a project phase of growth.
About Your New Job as a Quality Engineer Support design and development initiatives, including design controls, verification, and validation activities.Contribute to the development and validation of test methods and computer system assurance programs in line with regulatory requirements.Collaborate with cross-functional teams to uphold quality policies and objectives.Participate in risk management processes and usability engineering efforts.Support document control activities via an electronic QMS platform (QT9), including system administration.Lead or support investigations and resolutions related to CAPAs and non-conformances.Participate in internal and external audits, ensuring timely follow-up on any action items.Monitor and assess changes to relevant standards and guidance documents, conducting gap assessments as needed.Support supplier quality activities, including selection, evaluation, and maintenance of the Approved Vendor List.Perform additional tasks as needed to help meet business objectives and KPIs.What Skills You Need as Quality Engineer II A Level 8 NFQ in Engineering or Science.Minimum of 3 years' experience in medical device manufacturing.Familiarity with FDA and EU regulatory requirements, including QSR and ISO standards.Demonstrated ability to manage priorities, solve complex problems, and lead technical initiatives.Experience with CAPS and Validation essential.Knowledge of risk management principles (ISO 14971) and strong root cause analysis skills (e.g., DMAIC).Proficiency in MS Office suite and experience working in electronic QMS platforms.What's Next Apply now by clicking the "Apply Now" button or call us for more information.
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We also have multiple Temp, FTC, and Contract jobs available.
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