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Kaleidoscope Software Quality Engineer in San Francisco, California

Software Quality Engineer

Onsite Services
San Francisco, California

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Qualifications:

  • 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 60601-1

  • IEC 62366-1 and -2

  • ISO 13485

  • ISO 14971

    Key Responsibilities:

  • 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.

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