- Cognizant (Raleigh, NC)
- …Creek Policy experience in a functional role. . Experience in commercial lines templates ( ISO and non- ISO ). . Techno-functional experience in Duck Creek is a ... Policy functional roles. . Strong understanding of commercial lines templates ( ISO and non- ISO ). . Ability to collaborate effectively with technical leads and… more
- BorgWarner Inc. (Arden, NC)
- …new product line. This leadership role is critical to ensuring compliance with ISO and other relevant standards, while fostering a culture of continuous improvement ... with relevant QMS standards, with a strong preference for ISO and non-automotive standards. + Serve as the management...environment. + Deep understanding of QMS standards such as ISO and IATF; ISO or non-automotive standards… more
- WSP USA (Greensboro, NC)
- …scarcity, waste, and other impacts. + Producing reports (screening-level and ISO -conformant, comparative and non-comparative) and presentations based on the results ... the electronics and technology business sectors + Experience with developing ISO 14040 and ISO 14044 conformant LCA reports + Familiarity with the product design… more
- ThermoFisher Scientific (Wilmington, NC)
- …Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971. **Knowledge, Skills, Abilities** + Strong ... of manufacturing processes and product engineering change controls. eg ISO 9001, ISO 13485 + Awareness of international regulations, standards, and requirements… more
- Mentor Technical Group (Wilson, NC)
- …effectiveness. + Support the Quality Manager in Client Internal Audits. + Comply with the ISO Certifications ISO 9001 and ISO 17025. + Prepare evaluation ... reports and submit them to Quality & Customer Service Manager. + Function as an information source for bottlers and other departments when critical quality issues arise. + Establish and manage professional customer rapport to drive solutions to attain business… more
- 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