Quality Engineer II
hace 7 días
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).
- 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.
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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