Jobs in Walnut Creek, CA

About the role

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

What you'll bring

• A Minimum bachelor's degree in engineering, Science or related technical field.
• Minimum of 4-5 years of experience in software quality assurance or software validation
• 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 and experience of CSV activities but not limited to.
• GxP and 21 CFR Part 11 applicability/criticality assessment.
• Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
• Conduct Periodic Reviews of systems.
• Perform System Retirement of systems that are not in business.
• Understanding of Medical Device Quality and Compliance.
• Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
• Working experience in Product Lifecycle Management (PLM) too.