Quality Engineer II

hace 1 semana


San Rafael, Costa Rica ATL Technology Costa Rica A tiempo completo
Job Summary

The Quality Engineer II – Sustaining is responsible for maintaining and improving quality systems in a contract medical device manufacturing environment. This role ensures compliance with regulatory requirements, supports audits, and drives continuous improvement initiatives. The engineer will work cross-functionally to resolve quality issues, support qualified process maintenance, and contribute to sustaining activities across the site.

Requirements
  • Bachelor's degree in Engineering or a related science/technical/business field. Licentiate degree in Engineering is desirable.
  • 3 to 5 years in similar quality engineering roles, preferably in medical device manufacturing.
  • Familiarity with 21CFR820, ISO 13485, and ISO 14971 standards.
  • Internal Auditor training (preferred).
  • Intermediate to upper-intermediate English (B2+ level).
Responsibilities
  • Ensure compliance with regulatory obligations and maintain high-performance quality systems.
  • Support audits and respond to inquiries related to the Quality Management System (QMS).
  • Participate in CAPA processes and continuous improvement initiatives.
  • Standardize inspection methods and criteria using statistical tools and measurement system analysis.
  • Support Non-Conforming Material Reports and Material Review Board activities.
  • Lead cross-functional teams to ensure defect-free products and meet business and customer expectations.
  • Drive and support Transfer Projects, including validation activities, FMEA, and quality planning.
  • Analyze data from various functions and make quality recommendations.
  • Apply GD&T and blueprint reading skills.
  • Conduct and interpret Gage R&R studies.
  • Utilize metrology tools and techniques effectively.
  • Teach and implement new concepts in manufacturing and inspection.
  • Develop and implement sampling plans.
  • Support maintenance activities for qualified processes.
  • Assist with QMS activities such as training, documentation, CAPA, and supplier management.
  • Participate in sustaining and continuous improvement projects as needed.
About ATL Technology

ATL Technology is a contract manufacturer specializing in medical devices. Located in Flexi Park, Building G, San Rafael, Alajuela, Costa Rica, ATL is committed to delivering high-quality products through robust systems and continuous improvement. Our team works collaboratively across functions to meet regulatory standards and exceed customer expectations.


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