- Terumo Neuro (Aliso Viejo, CA)
- …sterilization expertise during interface with regulatory agencies, including FDA and ISO . + Support clean room monitoring and validation activities, including, but ... (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and...medical product sterilization and for cleanroom monitoring. 4. EN ISO 11135, EN ISO 11137, EN … more
- Alkegen (Sebring, OH)
- …for customer complaints; supports New Product Introduction (NPI); and helps maintain ISO 9001 and IATF 16949 Quality Management Systems through internal audits and ... through DFM/DFA principles. + Participate in maintaining and updating the ISO 9001 and IATF 16949 Quality Management Systems, ensuring compliance with… more
- ThermoFisher Scientific (Santa Clara, CA)
- …Quality Engineer maintains alignment with internal quality guidelines and regulatory mandates, covering cGMP, ISO 9001, ISO 13485, and ISO 14971. This role ... control systems, inspection protocols, and process controls aligned with GMP, GDP, ISO , and risk-management requirements. + Establish and monitor key quality metrics… more
- Alkegen (Council Grove, KS)
- …safety, and training. + Lead the implementation, maintenance, and continuous improvement of ISO 9001, ISO 14001, and ISO 45001 management systems. ... customer audits and ensure both plants maintain required certifications ( ISO , IATF, etc.). + Champion robust problem solving techniques...is required + Demonstrates hands on experience of implementing ISO 9001, ISO 14001, and ISO… more
- NANA Regional Corporation (Fort Sill, OK)
- …with contract specifications and applicable regulations. Conducts internal audits IAW ISO 9001:2015 in the Transportation Department that includes, but not limited ... Rail, TMP and Personal Property operations. The Auditor understands and applies ISO concepts, principles, and requirements. Inspects and audits all phases of a… more
- Synergy ECP (Annapolis Junction, MD)
- …the preparation of a work product in Technical Process Areas associated with ISO /IEC 15288. The ideal candidate will have a SIGINT background, experience with Linux, ... preparation of a work product in Technical Process Areas associated with the ISO /IEC 15288. + Perform systems engineering activities and assist in the preparation of… more
- Integra LifeSciences (Plainsboro, NJ)
- …and implementation of new and updated Quality System procedures for ISO /QSR, such as validation protocols, manufacturing procedures, product & material ... compliance with corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device… more
- Actalent (Sulligent, AL)
- …and Engineering Departments to verify the adequacy of the welding AWS or ISO 3834-2 processes ensuring correct execution. + Develop and document welding procedures ... that comply with AWS or ISO standards. + Implement quality assurance measures, including regular...including regular inspections, to verify compliance with AWS or ISO 3834. + Collaborate closely with the production engineering… more
- Eurofins US Network (North Brunswick Township, NJ)
- …activities are performed in compliance with both internal procedures and external cGXP/ ISO requirements. + Maintain the internal auditing program to ensure the ... laboratory compliance with respect to lab cleanliness, training records, and other ISO /GMP-related items, as needed to help minimize laboratory errors and audit… more
- Actalent (Maple Grove, MN)
- …and artwork alignment with FDA 21 CFR 801, EU MDR Annex I (GSPR 23), ISO -1, ISO , UDI/GS1, and IEC/UL marking requirements. + Identify appropriate marking ... technologies/materials to meet IEC and ISO Durability and Legibility requirements. + Systematically approach labeling with preparedness for global launch and… more