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Risk Management Specialist

3 weeks ago

Stockholm, Stockholm, Sweden SHL Group Full time

We are seeking a highly skilled Medical Device Quality Assurance Engineer to join our team at SHL Medical. In this role, you will be responsible for reviewing risk management related topics within Design and Development Projects and participating in the development, implementation and administration of SHL's risk management processes.

About the Job

The Risk Manager will carry out activities in accordance with SHL's QMS, following Quality Policy, Standard Operating Procedures and Work Instructions that apply to the position.

  • Support the project team to conduct the risk management activities and establish a risk management file.
  • Establish documents and approve established documents and records as Risk Manager.
  • Participate in design reviews as Risk Manager.
  • Be responsible for customer communication related to risk management activities in the customer design and development project.
  • Participate in the implementation and administration of SHL's risk management process in the Sweden office.
  • Participate in CAPAs and change controls as Risk Manager.

This is an exciting opportunity to work in a fast-growing and innovative industry with a dynamic, international team of highly skilled professionals.

Requirements

To be successful in this role, you will need:

  • 3-5+ years of relevant work experience.
  • Experience working with regulations and ISO standards, specifically EN ISO 14971:2019 and EN ISO 13485:2016.
  • Experience working with Risk Management, Quality Assurance, and/or Regulatory Affairs.
  • Engineering degree, such as mechanical engineering.
  • Fluency in English, speech and writing.

Please note that we do not accept applications from recruitment agencies for this role.