Provides support in the elaboration of internal RAQA documentation, participates in the maintenance and monitoring of the organization’s quality management system. |
Participate in the preparation and/or submission of technical and regulatory documentation in support of new and/or existing products certifications/registrations in Europe, US and other territories.
Provides support in the creation and follow-up of quality (procedures, quality plans, work instructions, forms, specifications, inspections plans, validation plans, qualification plans, templates, or any other quality document) or regulatory documents (technical documentation, regulatory assessments, regulatory intelligence database, trend reports)
Monitoring, improvement of internal processes and data gathering: follow-up the status of eQMS documents and processes, to ensure the system is under control and support the collection, analyzing, trending, and reporting of quality metrics.
Perform other duties as assigned.
Required:
Studying a life-science or engineering discipline.
Proficiency with PC computer and Microsoft Office software.
Fluent in English both written and oral.
Desirable:
Familiar with medical devices quality systems (ISO 13485 and FDA QSR) and/or medical device regulations (MDR, 21 CFR).
Commitment to quality.
High degree of concentration and analysis.
Observant and attention to detail.
Interested in quality and/or regulatory areas.