Katalysthealthcareslifesciences
Validation Engineer/CSV Engineer
Walnut Creek, CA, United States · Junior
Sponsorship not specifiedDetected 362 days ago
Product ManagementJiraTest AutomationClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceMedical DevicesResearchGxP
About the role
- All your information will be kept confidential according to EEO guidelines.
Responsibilities
- Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
- Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
Requirements
- A Minimum bachelor's degree in engineering, Science or related technical field.
- Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Experience with non-product software validation, including tools for development, testing, and maintenance.
- Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
- Working experience in Product Lifecycle Management (PLM) too.
- sound knowledge of computer system development lifecycles.
Nice to have
- Knowledge of JIRA, JAMA software and test automation is a plus. "
Benefits
- System Retirement/Decommissioning.
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
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