- Siemens Energy (Orlando, FL)
- …to supplier riskcategorization and audit program. Audits are according to ISO 9001 / 14001/ 45001. + NonconformanceManagement: Identify and initiate containment ... of NEC, NFPA, IEEE, and UL and knowledge and experience inauditing. ISO 9001, ISO 14001, ISO 45001 Lead Auditor certificationpreferred. + Understandingof… more
- Cordis (Miami Lakes, FL)
- …process/equipment validation (IQ/OQ/PQ) and test method validation (TMV) per 21 CFR 820, ISO 13485, and ISO 14971; set sampling plans and acceptance criteria. ... experience. **Preferred Qualifications** + Proven track record working within ISO 13485 and FDA-regulated environments. + Experience with process/product validation,… more
- Ryder System (Coral Gables, FL)
- …Cybersecurity RegulationAdditionally, experience in one or more of the following preferred: ISO 17799, ISO 27001, ITIL and NISTintermediate required + Experience ... Regulation. Additionally, experience in one or more of the following preferred: ISO 17799, ISO 27001, ITIL and NIST. intermediate required + Experience with one… more
- Cardinal Health (Tampa, FL)
- …liquid chromatograph, analytical balance, PTS, laminar flow hood and fume hood) + Works in ISO 7 cleanroom to make product vials and customer vials for use in drug ... production + Performs environmental and personnel monitoring in ISO 5, ISO 7, and ISO 8 environments + Coordinates daily production run schedule based on… more
- J&J Family of Companies (Jacksonville, FL)
- …for the chemical characterization of medical devices using LC/MS and GC/MS pursuant to ISO 119993-18 and ISO 11979-5. You will also be responsible for raw ... devices using high-resolution LC/MS and GC/MS + Perform extractables/leachable characterizations per ISO 10993-18 and ISO 11979-5 + Evaluate and introduce new… more
- Oracle (Tallahassee, FL)
- …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 (Tallahassee, FL)
- …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
- Kelly Services (Jacksonville, FL)
- …will be instrumental in improving equipment performance, ensuring compliance with FDA, ISO , and GMP standards, and supporting the deployment of innovative automation ... **Regulatory Compliance** Ensure all automation systems comply with FDA regulations, ISO standards, and GMP requirements specific to medical device manufacturing. +… more
- Oracle (Tallahassee, FL)
- …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
- Shapes Precision Manufacturing (Palm Bay, FL)
- …Quality Manager will be responsible for ensuring compliance with AS9100, ISO 9001, customer requirements, and regulatory standards, while driving continuous ... measurement tools and equipment. + Monitor compliance with AS9100, ISO 9001, and other relevant customer and industry standards....or lead role. + Strong working knowledge of AS9100, ISO 9001, and aerospace or regulated industry standards. +… more
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