Location: Temecula, California, United States
Job Summary:
Job Duties and Scopes
- Execute and maintain software quality engineering methodologies.
- Collaborate with R&D and Manufacturing Engineering for verification and validation processes.
- Create and execute software validation protocols.
- Implement code control and tracking systems.
- Conduct risk analysis and support quality audits.
- Develop and conduct training for software development and validation.
Required Skills
- Strong problem-solving and analytical skills.
- Advanced computer, statistical/data analysis, and report writing skills.
- Knowledge of regulatory standards (FDA, GMP, ISO 13485).
- Effective verbal and written communication.
Required Experiences
- BS degree in Engineering or Technical Field.
- At least 7 years of Software Quality Engineering experience.
- Familiarity with medical device industry preferred.
- ASQ CSQE certification desired.
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