Quality Assurance Engineer
Milano, Italy
6 gg fa

Job Summary

In our Milan Design Center, in Italy, we develop for the medical market.

For our expanding team, we are looking for a Quality Assurance Engineer.

The QA Engineer will be responsible for ensuring that all processes conform to internal quality system requirements (design control, in particular) and applicable international standards and are properly applied to projects in order to achieve coordinated results from all the areas involved.

What a typical day looks like :

  • Guide design team in conformance to the international standards (e.g. ISO 14971, ISO 13485, 21 CFR Part 820) applicable to product development
  • Serve as lead and coach in the implementation of design control and risk management requirements per above standards
  • Work within the design team to ensure that standard operative procedures are correctly used and maintained during the product development
  • Ensure that project data and technical documents related to product development process are managed according to document and change control procedure
  • Ensure the configuration control of the medical device Bill of Material and its transfer to the manufacturing sites (through Agile PLM)
  • Prepare and maintain the Design History File
  • Record and fill in relevant documents for QA
  • Supporting customers in quality assurance activities
  • Participates in ISO Certification and surveillance audits and customer audits
  • The experience we’re looking to add to our team :

  • Quality Assurance experience
  • Fluent English and Italian both in written and spoken form
  • We consider the following experience as a plus :

  • Graduate in Computer Science, or equivalent combination of education and experience
  • Broad theoretical understanding and practical knowledge of SW Quality Assurance - SW configuration processes / techniques in Product Development Process
  • JV34

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