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Quality & Regulatory Manager

Fluke Corporation is the world leader in the manufacture, distribution and service of electronic test tools and software with sound financial health. Fluke has achieved the number one or number two position in every market in which it competes. A wholly owned subsidiary of Fortive Corporation (www.fortive.com), Fluke is a multi-national corporation headquartered in the greater Seattle area. Working at Fluke gives you access to a robust career development process and challenging, “stretch” opportunities.

Fluke Health Solutions is a division within Fluke with the mission to ensure that all radiation technology optimally performs for workers and patients. It includes world leading brands like Landauer, Raysafe and Fluke Biomedical. Raysafe is the radiation centre of excellence based in Billdal offering customers world leading solutions for personal dosimetry and quality assurance in diagnostic X-ray. The business is in a growth mode with several product introductions in the coming year.

In this position you are responsible for quality management within Unfors Raysafe AB. You report to the Global RAQA Director. The Regulatory Affairs and Quality Assurance Manager will provide regulatory and quality engineering expertise, direction and hands-on involvement regarding quality processes, biomedical regulatory affairs, structures, and systems to drive continuous improvement in support of quality and compliance objectives.

We offer

  • Great colleagues who are passionate about their work
  • A possibility to learn about and follow interesting products from birth to re-birth
  • Make a change: we save lives by reducing radiation
  • A global organization

Qualifications

  • Bachelor’s degree (B.S.) in engineering from a four-year college or university.
  • Demonstrated ability to lead, grow in a Leadership position, and enable Team members to grow as well.
  • Solid experience in Regulatory and quality systems in an FDA regulated industry.
  • Working knowledge of Quality Management Systems – 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
  • Marked ability to learn new applicable standards, determine how they apply to the Business and provide related guidance cross-functionally.
  • Strong interpersonal skills with the aptitude to be a team player and Leader; setting a professional tone and establishing a cooperative partnership within the department and other areas of the Company to effectively resolve problems.
  • Ability to interpret trends and data, translating the information into actions, outcomes and improvements.
  • Formal training in quality engineering body of knowledge and tools, Certified RAPs and/or Quality Engineer desired.
  • In-depth knowledge of regulatory quality principles and technical tools (technical writing, problem analysis, control charts and other quality methodologies) with the ability to train others.

In this recruitment we are cooperating with K2 Search. For further information about the role please contact Lena Serner phone: 0702-900 995 or Samuel Göranzon phone: 0760- 001 874. All applications and contacts remain confidential. Selection is ongoing so do not wait to submit your application.