across all Operations & Maintenance (O&M) Contractor Work. This role ensures strict adherence to the Quality Management Plan (QMP), ISO 9001... in safety compliance and riskmanagement. The ideal candidate will have experience integrating quality and safety programs...
, but not limited to: ISO 13485 (Quality ManagementSystems for Medical Devices) IEC 62304 (Software Lifecycle Processes for Medical... Devices) ISO 14971 (Application of RiskManagement to Medical Devices) Maintain comprehensive documentation to support...
design control, riskmanagement, and regulatory compliance activities. This individual will play a key role in ensuring... Lead design control and riskmanagement activities for combination product development programs, ensuring all deliverables...
in Risk and Information Systems Control (CRISC);Certified Incident Handler (GCIH);Certified Information Systems Security... Professional - Information Systems Security Management Professional (CISSP-ISSMP);Certified Information Systems Security...
, etc. Experience in the application of RiskManagement (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL... within Client software, working closely with cross functional teams. Ensure riskmanagement files are meticulously developed...
, and external audits. Understanding of RiskManagement per ISO 14971. Familiarity with Premarket and Postmarket Cybersecurity... hoc/exploratory testing, cybersecurity, usability, and riskmanagement (including Design FMEAs and Hazard Analysis...
consultation to various departments on quality systems, regulatory compliance, and riskmanagement. 6. Conduct internal.... Responsibilities: 1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations. 2...
management, systems engineering, or business analysis on complex programs Demonstrated experience supporting Federal or DoD..., or related discipline Minimum of 10 years of experience in requirements management, systems engineering, or business analysis...
Integration Engineer to be a key contributor to the development of next-generation Thermal Systems. As the automotive industry... have... Bachelor's or equivalent combination of relevant education and experience. 3+ years of experience in embedded systems...
risk assessment, supplier self-assessment, onsite qualification audit, qualification database management. VEA (Value...Job Posting Start Date 03-27-2026 Job Posting End Date 05-29-2026 Crown Technical Systems, a Flex Company...