Software Quality Engineer
- 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,
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.