Quality System Specialist

HemoCue

Ängelholm, Sweden
Onsite
Daily management of capa
Daily management of vigilance
Daily management of audits
The role Quality System Specialist for HemoCue is responsible for daily management of CAPA, Vigilance and Audits within RA/QA

Job Summary

  • The role Quality System Specialist for HemoCue is responsible for daily management of CAPA, Vigilance and Audits within RA/QA.
  • You will be a part of the Quality System team at RAQA and report to the Manager, Quality Systems.
  • You’ll thrive in a culture of belonging where you and your unique viewpoint matter.

Matching Summary

The role Quality System Specialist for HemoCue is responsible for daily management of CAPA, Vigilance and Audits within RA/QA.

Skills & Requirements

Must-have

  • Daily management of CAPA
  • Daily management of Vigilance
  • Daily management of Audits
  • ISO 13485, IVDR compliance
  • Reviewing quality performance data

Nice-to-have

  • Continuous improvement culture
  • Critical thinking and prioritization
  • Supporting with additional tasks

Key Requirements

  • University Degree in Science or Technology
  • Minimum 3 years of experience
  • Excellent understanding of Medical Device/IVDs regulations
  • Fluent in English verbally and in writing

Work Rights

Not specified

Tailored Resume

Cover Letter