Quality Assurance Intern supporting QMS maintenance and software validation at Sonio. Engaging in compliance, documentation, and quality training initiatives.
Responsibilities
Support the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485
Write, review, and maintain quality documentation (procedures, work instructions, templates, records) and ensure proper document control
Support software validation activities, including validation documentation, traceability, and evidence maintenance
Assist in the management of nonconformities, complaints, and CAPAs (investigation support, documentation, follow-up, verification of effectiveness)
Contribute to continuous improvement initiatives and quality process optimization
Support the definition and monitoring of quality indicators (KPIs)
Support quality training activities, including the preparation, deployment, and follow-up of internal training and training records
Requirements
Currently enrolled in a Bac+5 level program (Master’s equivalent), preferably in the medical devices field (engineering degree, Master in Regulatory Affairs, etc.)
Knowledge of medical devices and software is a plus
Knowledge in quality and regulatory affairs is a plus
Fluent in French and English
Team-oriented with strong collaboration skills; this role will interact with most internal teams. We prioritize employee happiness and well-being and aim to be innovative in how we build the team
Benefits
Support the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485
Write, review, and maintain quality documentation (procedures, work instructions, templates, records) and ensure proper document control
Support software validation activities, including validation documentation, traceability, and evidence maintenance
Assist in the management of nonconformities, complaints, and CAPAs (investigation support, documentation, follow-up, verification of effectiveness)
Contribute to continuous improvement initiatives and quality process optimization
Support the definition and monitoring of quality indicators (KPIs)
Support quality training activities, including the preparation, deployment, and follow-up of internal training and training records
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