Junior Quality Assurance Specialist

We are looking for a Junior Quality Assurance Specialist for our Quality team.

Main responsibilities:

  • 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)

Requirements:

  • 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

Skills:

  • 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.

Let's work together