Software Quality Engineer

Engineering San Francisco, California

  • 2+ years of working experience in the Quality Engineering, Operations and/or R&D functions
  • 2+ years of experience with Medical Electrical Equipment (i.e., devices with embedded controls)
  • Working knowledge of statistical techniques, usability engineering and reliability engineering
  • Knowledge of regulations USA:

                        21CFR Part 11, 

21CFR Part 801, 21CFR Part 820

 Knowledge of International standards:

  • IEC 60601-1 
  • IEC 62366-1 and -2
  • ISO 13485
  • ISO 14971

 

  • Monitors and investigates process excellence techniques to identify systematic issues.
  • Participates in the development of equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability.
  • Provides expertise in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities.
  • Oversees that process and material quality objectives are met during product launch and are congruent with production requirements.
  • Develop and implements process and material quality targets.
  • Interprets and provides alterations to performance measurements to targets and provides remedial action directives as necessary.