Quality Engineer II (Sustaining)

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.