Quality Engineer I

hace 8 horas

San Rafael, Costa Rica ATL Technology, LLC A tiempo completo

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 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

ATL 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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