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About This Opportunity
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 quality ...