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

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comunidade metodistaSanta Clara (CA)
Validation EngineersElectromedical and Electrotherapeutic Apparatus Manufacturing

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About the role

Medical Device & Regulations Engineer job at Katalyst HealthCares and Life Sciences. Santa Clara, CA.
Responsibilities: 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 toRequirement Specifications (User, Functional. PlanQualification 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.
Requirements:
  • 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 21CFR Part 11 guidelines
  • Working experience in Product Lifecycle Management (PLM) tool.
  • Sound knowledge of computer system development lifecycles.
  • 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.

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