- Zimmer Biomet (Austin, TX)
- …Quality, Regulatory, and Clinical teams to ensure design compliance with FDA, ISO 13485, and other global regulatory standards and with suppliers and manufacturing ... design control, risk management, and change control procedures per ISO 14971 and 21 CFR Part 820. **What Makes...of design controls, risk management, and regulatory compliance (FDA, ISO 13485, ISO 14971) + Proficiency with… more
- NRG Energy, Inc. (Houston, TX)
- …Take or direct timely and appropriate real-time actions in accordance with ISO procedures. + Coordinate unit availability, outage schedules, unit startup and ... Communicate with Balancing Authorities, Reliability Coordinators, Transmission Operators and ISO on continual basis, taking necessary actions and providing ancillary… more
- Aerotek (Pflugerville, TX)
- …quality specifications. The ideal candidate will have a basic knowledge of ISO 9001 Standards. **Responsibilities** + Follow safety guidelines and understand safe ... Polymer Extrusion Systems + Preferred manufacturing experience within an ISO Quality System + Strong mechanical aptitude + Basic...Data Analysis + Root Cause Analysis + Understanding of ISO 9001 methodology and concepts **Why Work Here?** Join… more
- EDB (Austin, TX)
- …reduce inherent information risks. + Support the integration of new security frameworks, including ISO 27001 and ISO 42001. + Assist in the annual planning ... experience with auditing security objectives of SOC2, HIPAA, FedRAMP (800-53), NIST, and ISO 27001. + Ability to navigate compliance controls and cloud security best… more
- KBR (Houston, TX)
- …(industry-specific experience is a plus) + Deep familiarity with Quality Management Systems & standards ( ISO 9001, ISO 45001, ISO 55001, AS 9100, etc.) + ... Experience with the development and implementation of nonconformance management, audit management, and continuous improvement programs + In-depth knowledge of tools, concepts, and methodologies of Quality and Project Management + In-depth knowledge of… more
- Oracle (Austin, TX)
- …regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards. Key Responsibilities ... . Conduct and contribute to clinical risk analyses (per ISO 14971). . Collaborate on Failure Mode and Effects...within healthcare technology or medical devices. . Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance… more
- Oracle (Austin, TX)
- …documentation, Traceability Matrices, and Verification Plans. + Update and maintain ** ISO 14971-compliant risk management files** , hazard analyses, and FMEAs. + ... Experience with one or more of: + MDR (Medical Device Regulation) + ISO 14971 (risk management) + ISO 13485 + IEC 62304 + SaMD (Software as a Medical Device)… more
- Oracle (Austin, TX)
- …its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards and address ongoing patient safety, compliance, and product ... regulated healthcare software sectors. . Extensive experience in FDA, MDR, and ISO 14155 compliance, clinical risk management, and clinical evaluation for software… more
- Panelmatic Inc. (Houston, TX)
- …adherence to international, national, and industry-specific standards (such as IEC, HUD, NEC, IPC, ISO , IBC, UL, NFPA). + Job Duties: + Serve as the primary liaison ... agencies. + Strong working knowledge of electrical standards (eg, IEC, HUD, NEC, IPC, ISO , IBC, UL, NFPA etc.) + Proficient in reading technical drawings and using… more
- HP Inc. (Austin, TX)
- …organizations, and overall concepts of GRC, CMMC compliance, NIST CSF framework, ISO assessments; and assist with orchestrating evidence gathering, management of and ... Certification and readiness for critical assurance frameworks such as ** ISO /IEC 27001** , **CMMC Levels 1 & 2** ,...grasp of control frameworks such as NIST CSF, COBIT, ISO /IEC 27001, SOC 2, PCI DSS, HIPAA, and SOX.… more
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