medicines to those who need them, improve the understanding and management of disease, and give back to our communities through..., and interpret in silico models to support device development, design optimization, and technical risk mitigation across early...
& validation (V&V) Experience with materials, plastics, or electromechanical systems Knowledge of ISO 14971 (riskmanagement... Knowledge of design controls and regulatory requirements (FDA, ISO 13485) Experience with riskmanagement tools (FMEA, DFMEA...
, network security, endpoint posture, logging, and detection, while partnering closely with InfoSec on riskmanagement, POA&M...Umbra is an American space technology company delivering advanced systems, from sensors to spacecraft, that empower...
, EU MDR, and global regulatory needs. Contribute to requirements traceability (Jama/DOORS), riskmanagement (ISO 14971... and acquisition systems. Translate system requirements into FPGA architecture with complete traceability. High-Speed I/O & Data...
Architecture and Design Documents Actively participate in software riskmanagement and hazard analysis, integrating software... software risk and hazard analysis. Experience with version control and work item tracking systems such as Git and Azure DevOps...
., ISO 9001, IATF 16949) to support quality objectives. - Apply skills in statistical analysis, ERP, and Quality Management... Systems (QMS) for effective quality management. - Communicate effectively and solve problems;quality certifications (CQE...
Implementation Specialist Vendor RiskManagement Understanding of various regulations like GDPR, ISO etc. (Good... Integrations with other external systems Knowledge of one or more of the following: HTML/CSS, AJAX, Jelly, JSON, AngularJS...
validation (IQ/OQ/PQ). Proficiency in Lean, Six Sigma, and continuous improvement tools. Experience with riskmanagement (FMEA... to quality standards such as ISO 13485, FDA QSR, and GMP. Collaborate with R&D, Quality, and Supply Chain teams to support new...
, ISO standards, and Environmental, Health, and Safety (EH&S) managementsystems by following established policies..., reducing risk and enhancing profitability. Develop manufacturing strategies and manage tooling development to deliver quality...
to standards and best practices. Ensure full compliance with quality systems (FDA, GMP, QSR, ISO), product specifications... direct management of production personnel, fulfillment of the production schedule, and ensuring quality compliance. Provide...