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  • Location

    Belgium

  • Job title:

    Senior Software QA consultant

  • Sector:

  • Job ref:

    44906

  • Startdate:

    2020-09-11

The Company

Our partner is a highly innovative company operating worldwide.

 

Role description

We have an immediate need for a Senior level Software QA consultant for supporting our partner their software solutions.  The product has both IVD and RUO versions, and is a SaaS solution with deployments worldwide.  They operate under an ISO 13485 certified quality system, and within an ISO 27001 certified Information Security Management System.

 

We would start with a 6 month engagement the development, release, and operations for their platform, under our ISO 13485-certified QMS and ISO 27001 ISMS.  

 

Responsibilities

  • QA support for new software product releases are taken from concept, design, development to commercialization. In a year we have about 20-25 software releases in Leuven
  • Health Hazard evaluations associated with the complaints
  • Safety and non-safety customer notifications
  • Tracking and trending of Quality objectives on weekly and monthly basis
  • Supporting site notified body and internal audits
  • Develops, implements and maintains Quality Management system and activities within FDA QSR 820, ISO 13485, ISO 27001 and international regulatory guidelines
  • Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA.
  • Assist in complaints investigation, CAPA, Non- Conformances and Deviations.
  • Review and approve change requests and Change Orders.
  • Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards.
  • Create and / or update design and process FMEA. Review, create, and / or update traceability matrices.
  • Support Computer Systems Validation activities
  • Contribute to QMS updates and tools implementations supporting our transition to IVDR

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