Embedded Software Engineer developing safety - critical embedded software for various industries in Neu - Ulm. Collaborating on projects ensuring safe products through safe processes.
About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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