environment. Knowledge of ISO or AAIS, Excel and SERFF is a plus. TO BECOME A WORK-AT-HOME VINTAGE EXPERT, WE REQUIRE 25...
an ISO 9001-2015 certified Quality Management System. Prism Maritime is an EEO/AA employer. We invite resumes...
and established procedures Responsible for assuring departmental compliance with ISO and FDA requirements through supporting... requirements including 21 CFR 820, ISO 13485, ISO 14971 Familiarity with GMP and regulatory requirements for medical devices...
calibration, troubleshooting, maintenance, and repair of GPTE and calibration standards. Relevant experience with ISO 17025..., Joint Naval Audit Certification, Navy quality control, or similar. ISO 9001:2015 experience or equivalent...
rules, and regulations. Ability to analyze and interpret various bureaus (ISO, AAIS, and/or NCCI) and/or company...
mobility, or safety-critical systems. Familiarity with ISO 26262 or other safety standards Compensation There are three...
of experience working with automated liquid handlers and associated software in a regulated environment (CLIA, CAP, ISO...
. Complies with applicable Werfen standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System...
by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC...
and implement quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant regulatory requirements..., ISO 13485, and other relevant standards. Proven track record of successfully managing a quality assurance team in...
, management of change for ISO 40001, OHSAS 18001, ISO 9001 Familiarity with enterprise resource planning systems, e.g., Oracle...
obligations including, but not limited to, occupancy permit/business license, fleet compliance and ISO quality systems...
. Requirements Minimum Bachelor’s degree in Science or related field. ISO 13485:2016 lead auditor certification preferred.... Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. Strong understanding...
obligations including, but not limited to, occupancy permit/business license, fleet compliance and ISO quality systems...
to ISO 9000 or AS9100 standards. Familiarity with quality tools: SPC, FMEA/PFMEA, Kaizen, Fault Tree Analysis. ASQ...
, ISO 27001, GDPR, or PCI-DSS. Relevant certifications (e.g., CISSP, CEH, GIAC, CISM, or equivalent) preferred...
improvements. Maintain lab notebook in a clear, complete, and consistent manner, following all legal, ISO, and QSR requirements... and/or next-generation sequencing (NGS) and genomics. Demonstrated understanding of GMP, ISO, and Quality Systems. Demonstrated expertise...
Exposure to ISO 9001, CMMI, or AS9100 Outstanding communication skills Demonstrated teamwork and leadership experience...
Management System (QMS) experience that is compatible with ISO 9001:2008. REMARKS Must be able to communicate effectively in...
, etc.) during downtime events to minimize disruption and ensure swift recovery of manufacturing lines. Ensure compliance with QMS and ISO...), and other continuous improvement tools. In-depth knowledge of Quality System Regulations (QSR), risk assessment tools (PFMEA), and ISO...