Software Quality Engineer (Onsite Services)

Engineering San Francisco, California

Required skills:

Knowledge of regulations USA:

  • 21CFR Part 11, Electronic records and signature
  • 21CFR Part 801, Labeling
  • 21CFR Part 820

Knowledge of International standards:

  • IEC 60601-1 
  • IEC 62366-1 and -2
  • ISO 13485
  • ISO 14971      
Working knowledge of statistical techniques, usability engineering and reliability engineering.

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.

Expertise in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process non-conformities.

Develop and implements process and material quality targets.

Interprets and provides alterations to performance measurements to targets and provides remedial action directives as necessary.


  • Experience with devices that have embedded controls.
  • Experience in the medical device industry.

  • Self-directed, able to work with minimal supervision
  • Adaptable to shifting priorities
  • Able to handle rapid pace environment