5 days ago Be among the first 25 applicants
In Galway, there's a standout example of a global medtech operation that has quietly become one of the region's most important engineering and manufacturing hubs.
For nearly three decades, this large international facility has grown from a modest beginnings into a powerhouse campus where thousands of innovative medical devices are designed, developed, and exported around the world each year — from advanced stents to precision catheter technologies that help treat cardiovascular and other serious conditions.
About Your New Job as a Quality Engineer
Demonstrate commitment to the Quality Policy through daily execution of sound quality practices and maintenance of an effective quality system.
Identify and resolve complex exceptions to work assignments, analyze test results, and make appropriate decisions.
Independently make decisions related to product quality, including the disposition of non-conforming products.
Participate in customer complaints investigations and drive improvements in product and process quality.
Promote awareness of MDR and QSR standards, and make appropriate decisions utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
Be fully conversant with validation techniques and associated regulatory requirements, including analysis of customer feedback and complaints.
Compile and analyze operational, test, and validation data to establish technical specifications and performance standards.
Participate in new product/technology transfers to ensure compliance with all internal and regulatory requirements.
Use Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems and improve quality.
What Skills You Need as a Quality Engineer
NFQ Level 8 Honours Degree (240 Credits) in an Engineering or Science related discipline.
A minimum of 3+ years' experience working at an Engineering level, ideally within the Medical Device industry or another highly regulated environment such as Food, Automotive or Pharma.
Familiarity with Internal Audit Processes.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Manufacturing, and Production
Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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