Medical Device & Regulations Engineer at Katalyst HealthCares and Life Sciences Santa Clara, CA

Medical Device & Regulations Engineer job at Katalyst Health Cares and Life Sciences. Santa Clara, CA.

• Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
• Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
• Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
• Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
• Creation and review of validation deliverables including but not limited to
• Requirement Specifications (User, Functional.
• Plan
• Qualification Protocol (Installation, Operational, Performance)
• Reports (Summary, Exception) of protocol execution§ Traceability Matrix.
• Periodic Reviews.
• System Retirement/Decommissioning.
• Execution of Dry/Test protocol run.
• Conduct Periodic Reviews to determine if the system is in a validated state and take appropriate actions.
• Perform System Retirement/Decommissioning of systems not in business
• Work closely with software development and IT teams to establish best practices for quality and compliance.
• Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
• Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

• 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, preferably within the medical device industry.
• 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.
• Execution of Dry/Test protocols§ 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 21
  
  CFR Part 11 guidelines
• Working experience in Product Lifecycle Management (PLM) tool.
• Sound knowledge of computer system development life cycles.
• Knowledge of JIRA, JAMA software and test automation is a plus.
• Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.