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.
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.
- S. 5+ years related experience in Mechanical or Plastics Engineering for medical devices
M.S. 3-5 years related experience in Mechanical or Plastics Engineering for medical devices
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
- 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 email@example.com.