- ThermoFisher Scientific (Pittsburgh, PA)
- …environments with applicable regulations/standards to GSG business including 21CFR820, 21CFR803, ISO 9001, ISO 13485, IVDR, cGMP's, FDA Guidelines, USP, ... regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485, and ISO 1497. + Detailed knowledge of software validation best practices; especially… more
- York Precision Machining and Hydraulics (York, PA)
- …calipers, CMMs), documenting results to confirm adherence to customer and ISO standards. + Document Inspection Results Accurately record inspection outcomes, ... equipment is properly calibrated, maintained, and functioning in accordance with ISO 9001 requirements. + Interpret Technical Documentation Read and interpret… more
- Envista Holdings Corporation (Quakertown, PA)
- …+ Execute process improvements as they relate to QMS compliance with ISO /GMP requirements + Identify and drive Corrective and Preventive Actions (CAPA) related ... of experience in progressive Quality Assurance role and exposure to FDA regulations/ ISO 13485 requirements. + Experience with statistical software packages such as… more
- Envista Holdings Corporation (Quakertown, PA)
- …maintenance as applicable. + Obtains product certification/recognition to applicable EN, ISO & IEC 60601-1 general, collateral, and standards through 3rd party ... Has developed FMEA, Risk Analysis and Usability Engineering documentation ( ISO 14971 highly desirable). + Experience with FDA 510K...and has contributed to 510K submissions. + Experience with ISO quality management systems and processes ( ISO … more
- KTA-Tator, Inc. (Pittsburgh, PA)
- …weeks to certify new inspection instruments, receipt inspect customer instruments, perform ISO and non- ISO calibrations, assemble kits, and produce certificates. ... precise calibrations to maintain the highest standards of accuracy. + ISO -Accredited Calibrations: Provide ISO -accredited calibrations upon request, ensuring… more
- WSP USA (Bethlehem, PA)
- …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
- Amcor (Pittston, PA)
- …Manager + Review and inspect trailers as a final decision based on safety and ISO /SQF standards + **_MyDevelopment Course:_** _Key Principles of ISO 9000_ + Must ... ensure complete communication as needed + Understands and will adhere to all ISO & SQF guidelines and policies **Qualifications** **Additional Info** + High School… more
- Jabil (West Chester, PA)
- …lead the preparation/readiness activities for external audits (Customer Audits , ISO Certification audits and Health Authorities Inspections). As required, you will ... with all applicable standards and regulatory requirements such as ISO 13485, 21 CFR 820 and ANVISA. In this...system regulations, standards and best practices (21 CFR 820, ISO 13485) + Lead Auditor or Lead Assessor Certification,… more
- Actalent (Allentown, PA)
- …software to monitor and improve processes + Ensure ongoing compliance with ISO 9001 standards + Oversee Production Part Approval Process (PPAP) documentation and ... technical experience + Hands-on experience with APQP, PPAP, and ISO 9001 systems + Proficiency in statistical analysis and...or heavy truck manufacturing environments + Experience working with ISO and IATF 16949 management systems + Knowledge of… more
- Lumen (Harrisburg, PA)
- …quantify, and prioritize security risks utilizing industry-standard methodologies such as ISO /IEC 27005 and NIST. + Advise on remediation strategies for identified ... into security architecture. Align architectural frameworks with relevant standards (eg, ISO 27001, NIST, GDPR, HIPAA, SOX). + Recommend security policies, standards,… more