- Oracle (Raleigh, NC)
- …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 (Raleigh, NC)
- …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
- Danfoss (Forest City, NC)
- …and rapid improvement events. + Support Quality Manager: Ensure compliance with ISO 9001 and IATF 16949 standards, maintaining certification and supporting audits. + ... and Process Failure Mode Effects Analysis (PFMEA). + Support ISO 9001 and IATF 16949 certifications, audits, and document...pursuit of an engineering degree). + Proficient knowledge of ISO 9001 and IATF 16949 (training available for new… more
- Oracle (Raleigh, NC)
- …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
- GRAIL (Durham, NC)
- …principles in accordance with GRAIL's quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related ... working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements. +… more
- NANA Regional Corporation (Fort Bragg, NC)
- …compliance with US Army logistics regulations, contract requirements, and ISO 9001:2015 standards, while providing data-driven recommendations to improve efficiency, ... to track nonconformances and corrective actions. + Provide analytical support for ISO 9001:2015 compliance and performance monitoring. + Contribute to development of… more
- ARCO (Raleigh, NC)
- …& Audits** + Ensure adherence to local, national, and international regulations (eg, ISO , OSHA, ANSI). + Oversee internal and external audits, including after action ... + Certifications: Certified Quality Manager (CQM), Six Sigma Black Belt, or ISO Lead Auditor preferred. + Technical Skills: Expertise in QMS software, statistical… more
- Jabil (Salisbury, NC)
- …process quality across our cloud business at Salisbury. + You will lead ISO 9001:2015 systems, build control plans and quality gates from New Product Introduction, ... Etc.) and Incoming Quality Criteria(s). QMS Leadership: + Maintain and improve ISO 9001:2015 processes, work instructions, and records for the cloud product line;… more
- Broadcom (Durham, NC)
- …changes in regulatory, security, and privacy requirements (eg, SOC 1/SOC 2, ISO 27001/27017/27018, HIPAA, PCI) and assess their impact on product offerings. + ... + Strong understanding of security, privacy, and compliance frameworks (SOC, ISO , NIST, etc.). + Proven experience project managing security compliance audit… more
- Eaton Corporation (Fayetteville, NC)
- …Develop and maintain robust quality processes, consistent with Eaton Quality System, ISO , and Eaton Lean practices by creating Standard Work, Work Instructions, ... and Line Alerts and training operators for same. C. ISO Lead Auditor: Conduct quality audits of equipment and...and Error Proofing. * EESS Safety Training * Trained ISO Internal Auditor. * Experience with hand tools and… more