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Careers 2017-10-24T21:25:50+00:00

ThermoGenesis, a wholly owned subsidiary of Cesca Therapeutics, is a pioneer and market leader in the development and commercialization of automated technologies for cell-based therapeutics and bio-processing. We’re dedicated to advancing technologies and improving lives.

Open Positions

Quality Engineer (Disposables) to:

  • Support the manufacturing of Disposable Devices to achieve quality and business objectives through sustaining and continuous improvement activities.
  • Ensures compliance to 21CFR820, ISO 13485, the Medical Device Directive, other applicable regulatory and industry standards.
  • Effectively asses risk of design changes and process controls to assure high quality.
  • Analyze quality system data (field complaints, nonconforming product, etc.) to identify adverse trends and opportunities for continuous improvement.

Required Qualifications:

  • S. 5+ years related experience in Mechanical or Plastics Engineering for medical devices
    • -OR-

M.S. 3-5 years related experience in Mechanical or Plastics Engineering for medical devices

  • -OR-

Demonstrated equivalence and/or potential.

  • Experience in Root Cause Analysis and Corrective Action/Preventative Action (CAPA)
  • Product Risk Management throughout the product lifecycle
  • Standard statistical principles, theories, concepts, and techniques
  • Design Controls in accordance with 21 CFR 820
  • Quality Management Systems (ISO 13485, 21 CFR 820)
  • Failure investigations in a manufacturing environment
  • Blue print reading and interpretation including Geometric Dimensioning and Tolerance (GD&T) is preferred
  • Experience with contract manufacturing operations

Skills

  • High performing leadership skills, prioritization, communication (verbal and writing)
  • Self-starter, motivated, able to prioritize tasks and meet deadlines
  • Excels in use of Microsoft Office suite and statistical analysis software such as Minitab
  • Process Excellence (Six Sigma) and/or ASQ certifications is preferred

 

ThermoGenesis is an Equal Opportunity Employer.  If you are interested and meet these qualifications, please forward your resume to Human Resources at hr@thermogenesis.com.