Overview QMS Auditor - ISO9001 Lead Auditor Industry: Aerospace/Defense Position: QMS Audit Location: Caldwell... examination of the Quality Management System (QMS) and its various elements and procedures in order to ensure its effectiveness...
. Lead internal audit program, act as site contact for external audits (customer/regulatory), ensure audits (Internal... with FDA, GMP, ISO, and other standards; monitor/report KPIs (CAPA effectiveness, audit scores, complaints, training); present...
and reports any concerns impacting Quality. ● Provides support through site audit preparation, ISO 9001-2015 Internal... & External, Customer Audits days and support through assigned audit findings and proper corrective and preventive actions...
confirmation. Reject/document any off-spec packaging or filling defects. Post-Fill & Shipping QA (100% Audit) Perform 100... relevant to both the Environmental Management System (EMS) and the Quality Management System (QMS), including but not limited...
, and audit readiness. Career development. You will join a collaborative QA team that values transparency, respect, and learning... all documentation is accurate and audit-ready. Support investigations. You will assist in deviation investigations, including...
, as well as required business travel Responsibilities QRC Risk Management and Compliance Program (80%) Conduct QMS... internal data audit activities (per ISO 13485 and/or applicable regulatory standards) related to AEM, MMD, EOL/EOS and PM...
inspections and surveys QRC Tools, Processes and Program (30%) Lead QMS internal audit activities (per ISO 13485, 27001... Specialists with reporting criteria and analysis of effectiveness verification post audit and CAPA completion Identification...
Improvement Analyst. The 3 years of experience with the Bachelor’s degree must include experience with QMS requirements including... operated. Support the maintenance of the facility’s Quality Management System based on ISO9001 for continuous audit readiness...
and Infrastructure and applications Support the Process Control Validation Plan, CSV, Quality Documents, SOP’s and Audit Readiness... business processes such as audit, investigation and CAPA Monitor, Administer and optimize Automation Quality deliverables...
and Abilities Understanding and application of QMS principles (CAPA, change control, audit readiness). (High proficiency) Use... preferred. ISO and FDA audit experience (Preferred) To Staffing and Recruiting Agencies:Our company does not accept...
quality assurance activities as required or directed by management. Monitor and report level of QMS implementation..., compliance and effectiveness through audit activities, observation, review of quality metrics and customer feedback. Support QA...
procedures and components of the QMS and the business's quality objectives. Read and interpret customer quality system... requirements, including processing and inspection specifications. Audit business procedures and functions, including processing...
. Monitor and report level of QMS implementation, compliance and effectiveness through audit activities, observation, review...
. Lead internal audit program, act as site contact for external audits (customer/regulatory), ensure audits (Internal... with FDA, GMP, ISO, and other standards; monitor/report KPIs (CAPA effectiveness, audit scores, complaints, training); present...
and report level of QMS implementation, compliance and effectiveness through audit activities, observation, review of quality...
of Quality Management System (QMS) procedures related to regulatory compliance. Review, develop, and maintain SOPs, policies... to associates on regulatory requirements and compliance practices. Maintain up-to-date records and reporting to support audit...
compliance, audit readiness, and continuous improvement initiatives. Key Outcomes Expected Manage the creation, revision.... Knowledge of quality management systems (QMS) and compliance processes. Physical Demands Physical movements including...
of audit readiness. The Manager will implement, maintain, and continuously improve the Quality Management System (QMS..., implement, and maintain a compliant Quality Management System (QMS) in accordance with cGMP, GDP, FDA, and ICH guidelines...
and report level of QMS implementation, compliance and effectiveness through audit activities, observation, review of quality...
as required or directed by management. Monitor and report level of QMS implementation, compliance and effectiveness through audit activities...