Job SummaryATL 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 standards
Internal Auditor certification (preferred)
Fluent in English as a second language, with strong verbal communication skills
Responsibilities
Lead and collaborate with cross-functional teams using the Product Development Process to ensure quality systems and controls
Drive and participate in transfer projects, including qualification processes, test method validation, inspection methods, validation master plans, FMEA, and quality plans
Analyze complex or adverse situations, gather data from various functions, and make fact-based quality recommendations
Interpret engineering drawings and apply GD&T (Geometric Dimensioning and Tolerancing)
Conduct and interpret Gage R&R studies
Apply hands-on metrology skills across a wide range of tools
Train and implement new concepts in manufacturing, engineering, and inspection
Develop and implement effective sampling plans
Support continuous improvement projects and qualified process maintenance
Contribute to quality system activities including training, CAPA, documentation, and supplier management
About ATL TechnologyATL 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.Job Posted by ApplicantPro
