Junior Quality Assurance Specialist
We are looking for a Junior Quality Assurance Specialist for our Quality team.
- Support in the management of company medical device manuals
- Updating internal procedures and working instructions
- Support to the team in audit activities and preparatory activities to certifications
- Support in regulatory activities for stand-alone SW at EU level (EUDAMED Registration and Maintenance and UDI Management)
- Support in regulatory activities for stand-alone SW at FDA level (QMS adaptation to FDA requirements, database maintenance and UDI management)
- Degree in Biomedical Engineering
- At least 6 months experience in the same role in modernly organized companies – sw medical device sector is a plus
- Knowledge of ISO 13485, IEC 62304 and ISO 14971
- Fluency in English
- Excellent use of PC, Office package: Excel, Word, e-mail
- Strong analytical and problem solving skills
- Excellent interpersonal and communication skills
- Organization, analysis and accuracy
- Strong propensity for in-depth updating
We are looking for candidates with spirit of initiative and resourcefulness: everyone has the opportunity to get involved directly in Digitec and grow in a context that makes teamworking its strength.
The role is based in Lecco.
We offer a temporary contract – 12 months.