
Quality Engineer
- San Agustín de Guadalix, Madrid
- Permanente
- Tiempo completo
- Lead and support quality engineering activities related to medical device packaging, including design input/output, verification, validation, and risk management.
- Ensure packaging systems comply with applicable regulatory standards (e.g., ISO 11607, FDA).
- Conduct and support packaging process validations and test method validations.
- Participate in packaging-related change control and assessment of change requests.
- Handle packaging-related non-conformances, deviations, and CAPA investigations.
- Collaborate with R&D, manufacturing, and suppliers to ensure robust packaging design and performance.
- Support internal and external audits with a focus on packaging systems and documentation.
- Contribute to post-market surveillance and continuous improvement of packaging quality.
- Wiliness to travel (5%)
- Engineering and/or scientific related university degree
- 1-3 years of experience in Quality
- English - Advanced both spoken and written
- Ability to work multi-functionally and manage multiple priorities.
- Familiarity with packaging validation and regulatory requirements (e.g., ISO 11607).
- Familiarity with design control and risk management principles.
- Working knowledge of statistical analysis and sampling plans
- Strong communication and documentation skills