Senior Quality Engineer | Catalyst

Senior Quality Engineer

  • Posted: 24/10/2023
  • Salary: $100,000 - $125,000
  • Location: Austin, Texas, United States
  • Job Type: Permanent/Fixed Term
Opportunity to join a Digital Health organization as they ramp up their clinical & quality operations to bring to market their software medical device that is used in treating a disease that could eventually affect almost everybody in their lifetime. 

Main Responsibilities
 
  • Design and implement documentation and methods for quality management system according to FDA and ISO:13485 requirements 
  • Write and update quality documentation in collaboration with stakeholders in company
  • Design, implement and maintain electronical archival and document control for the company, with the help of subcontractor.
Experience Required
 
  • Bachelor's degree in Engineering or equivalent.
  • 3 years’ experience in Quality within the Medical Device industry, preferable with Software in a Medical Device.
  • Ability and willingness to go onsite in Austin 3 times a week.
Callum Sparkes Director

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