Software Quality Engineer (Onsite Services)
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
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