- EDB (Raleigh, NC)
- …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
- United Therapeutics (Research Triangle Park, NC)
- …situations, and deadlines + Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, ... 21 CFR Part 11, 210, 211, and 820 + Clear understanding of US FDA, EU, and JP GMP regulations + Knowledge of software validation practices and data integrity initiatives + Familiarity with pharmaceutical operations (ie, aseptic filling, etc.), solid oral dose,… more
- ALBEMARLE (Charlotte, NC)
- …Quality Management System (QMS) in accordance with corporate and regulatory standards (eg, ISO 9001, GMP, IATF 16949) + Partner with site teams to ensure consistent ... years' experience leading professional teams + Strong knowledge of ISO 9001:2015 and industry standards, including ISO ...of ISO 9001:2015 and industry standards, including ISO 17025 and IATF 16949. + Demonstrated experience managing… more
- 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
- 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