Kaleidoscope Software Quality Engineer in San Francisco, California
Software Quality Engineer
San Francisco, California
6-10 years of working experience in the Quality Engineering, Operations and/or R&D functions
6-10 years of experience with Medical Electrical Equipment (i.e., devices with embedded controls)
3+ years of experience project management
Working knowledge of statistical techniques, usability engineering and reliability engineering
Knowledge of regulations USA:
21CFR Part 11, Electronic records and signature
21CFR Part 801, Labeling
21CFR Part 820
Knowledge of International standards:
IEC 62366-1 and -2
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 non-conformities.
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.
May provide technical leadership across functional teams on many different process improvements.