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Quality and Compliance Specialist in Industry Software, Operational Excellence

Stockholm, Skellefteå, Malmö, Luleå, Linköping, Göteborg

Regular

Business Support

05 October 2021 - 04 January 2022

Industry Software

Quality and Compliance Specialist in Industry Software, Operational Excellence

We’re looking for experienced Quality and compliance specialist to join our Industry Software Operational Excellence team to help and support our Industry Software units meeting quality and compliance requirements in various business areas globally.

Working as a quality and compliance specialist is both challenging and rewarding. You need to have knowledge of quality management system standards, medical devices related standards and medical device regulation (MDR). In addition, you have a good understanding of the agile software development practices.

In a nutshell, in our Operational Excellence team, you get to:

  • Join a team of highly skilled quality and compliance experts
  • Work in a network, collaborating with experts and teams in matrix organization
  • Help business to achieve compliance to applicable standards and regulatory requirements, especially in the medical device area, by guiding and supporting the business units in close co-operation
  • Identify best practices and promote harmonization of way of working within Industry software.
  • Ensure alignment with corporate process framework and support unit level process management.
  • Secure that there are trainings, tools and techniques available for all employees related to applicable regulatory requirements and processes.
  • Identify areas of weakness, recommending and implementing improvements. Create and manage effective action plans in response to audit discoveries and compliance violations.
  • Support the business units in different audit-related activities.

To succeed in this role, you should have:

  • Strong experience of ISO certifications and Quality management systems relating to medical devices (for example ISO 13485).
  • Good knowledge of EU (i.e. MDR) and Swedish medical device legislation
  • Expertise on medical device software development practices, especially agile development
  • We value understanding on various medical device software related standards (i.e. IEC 62304, IEC 62366, ISO 14971, IEC 82304
  • University degree
  • Good communication skills and fluency in Swedish and English (both spoken and written)
  • Self-managed and proactive but enjoy working in a team
  • Natural ability to work in global, virtual environment and collaborate with people across different cultures and areas of expertise

Industry Software provides software products for clients in the public, healthcare, and welfare sector as well as in the forest and energy industries. Focusing on developing and running modern and scalable software platforms, we employ some 3 600 software professionals in over 20 countries. Industry Software Operational Excellence team works closely with leadership, business units, legal, HR, authorities in different countries and of course with our customers. Our aim is to support Industry Software business units to deliver world class software products and solutions to our customers

At TietoEVRY, we offer you professional growth, meaningful work, open culture and an outstanding work-life balance. Do you have earlier experience around quality and compliance? Do you take initiative and are ready to dive into the center of events? We are waiting for you to help us accelerate our growth!

 

About TietoEVRY

Welcome to an exciting journey. TietoEVRY creates digital advantage for businesses and societies. We are a leading digital services and software company with local presence and global capabilities. Nordic values and heritage are the foundation of TietoEVRY success. Let's build a brighter future. Together

Read more about us here.

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