Sr. Quality Engineer – Digital Health

posted on January 11, 2022

Job Description

Location: Chicago, IL

Duration: Permanent

Responsibilities:

  • Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area
  • 3+ years of industry experience in Quality Assurance, Development or healthcare related field
  • Experience in Medical devices, specifically development of Software Medical Devices is desired
  • Strong understanding of regulations and standards affecting SaMD such as IEC 62304, 21 CFR 820.30 and EU MDR
  • Experience with creation and maintenance of QMS documents for development of medical devices
  • Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
  • Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation)
  • Practical experience in design control and risk management
  • Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
  • Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
  • Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
  • Capable of clearly presenting and justifying quality requirements to management

 

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