Responsibilities

• Represent Quality in cross-functional projects, ensuring compliance with regulatory and internal quality standards.
• Participate in the execution of quality functions in compliance with FDA QSR, ISO 13485, and ISO 4971, and other national and international standards.
• Support process verification and validation activities (IQ/OQ/PQ), including documentation and reporting.
• Collaborate in the development and update of manufacturing documentation, including procedures, work instructions, and risk management (e.g., FMEA).
• Analyze manufacturing issues and non-conformities to identify root causes and drive continuous improvement actions.
• Support supplier quality activities (audits, validations, changes) and participate in internal and external audits.

Qualifications

• Fluent in English (bilingual).
• 5–10 years of experience in the medical manufacturing industry as a q...