Job Summary
ATL Technology is seeking a Quality Engineer to join our team in San Rafael, Alajuela, Costa Rica. This role is responsible for leading and supporting cross-functional teams to ensure robust systems and controls are in place to deliver defect-free products that meet business goals and customer expectations. The ideal candidate will have strong problem-solving skills, experience in metrology, and a solid understanding of quality systems in the medical device industry.
Requirements
- Bachelor's degree in Engineering or a related science / technical / business field (or 3 years of relevant experience)
- Engineering Licentiate degree (preferred)
- Knowledge and / or training in :
21 CFR 820 (Quality System Regulation for medical devices)
ISO 13485 and ISO 14971 standardsInternal Auditor certification (preferred)Fluent in English as a second language, with strong verbal communication skillsResponsibilities
Lead and collaborate with cross-functional teams using the Product Development Process to ensure quality systems and controlsDrive and participate in transfer projects, including qualification processes, test method validation, inspection methods, validation master plans, FMEA, and quality plansAnalyze complex or adverse situations, gather data from various functions, and make fact-based quality recommendationsInterpret engineering drawings and apply GD&T (Geometric Dimensioning and Tolerancing)Conduct and interpret Gage R&R studiesApply hands-on metrology skills across a wide range of toolsTrain and implement new concepts in manufacturing, engineering, and inspectionDevelop and implement effective sampling plansSupport continuous improvement projects and qualified process maintenanceContribute to quality system activities including training, CAPA, documentation, and supplier managementAbout ATL Technology
ATL Technology is a global leader in interconnect solutions, specializing in custom medical device assemblies. With a strong commitment to quality and innovation, we partner with leading OEMs to bring life-enhancing technologies to market. Our Costa Rica facility, located in Flexi Park, San Rafael, Alajuela, is a key part of our global operations, offering a dynamic and collaborative work environment.
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