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Quality Systems Engineer (PMS)

  • Location

    Brisbane

  • Salary

    US$95000 - US$115000 per year

  • Sector

    Forschung und Entwicklung Engineering Compliance

  • Job Ref

    27562

  • Contact

    Kylie Fehrenbach

  • Published

    17 Tage her

Übersicht

The Quality Systems Engineer (PMS) will be responsible for ensuring compliance of the QSR to all applicable regulations and standards & working cross-functionally with various teams to execute the transition EU Medical Device Directive to EU Medical Device Regulation.

Requirments:

  • B.S., Life Science, Engineering, or related
  • Minimum 2-4 years experience in a highly regulated Medical Device space
  • Strong experience with applicable medical device regulations such as EU MDR, 21 CFR 820, ISO 13485:2016, ISO 14971:2019 and MDSAP
  • Proficient in Microsoft Office suite, SPC tools
  • Excellent planning, collaboration, and communication skills
  • Attention to detail & ability to work in a fast paced environment
  • Lead auditor experience preferred