Develop, implement and maintain Quality Assurance procedures (SOP’s) and policies in support of the Quality Management System for the Mahwah site.
Authority to issue, review and approve documents with administrative oversight of the Document Management Process and Change Control.
Train and educate in the Quality Management System. Create and maintain training matrices and administration of training records associated with the Quality Management System.
Report on a regular basis the status of the Quality Management System via analysis of quality data inputs from QA and other functions as appropriate.
Collect, organize, analyze, and provide data, information, and/or trend reports for management review in a format that clearly communicates the results. Provide feedback data for Post Market Surveillance.
Plan and conduct periodic internal / external quality audits and preparation of documents of report findings and any corrective actions to assure that the quality management system is in compliance with established requirements and to determine its effectiveness.
Support regulatory inspections regarding quality systems.
Provide guidance and/or collaborate routinely with all functions (local & global) to ensure that quality system requirements are maintained and/or will be met.
Support review, analysis, evaluation and corrective actions associated with reported adverse events and customer complaints.
Qualifications
Bachelor’s degree from a four-year College or University in an engineering discipline.
Experience with 21 CFR 110 and 111
Experience with GMP and ISO 9001
Develop, implement and maintain Quality Assurance procedures (SOP’s) and policies in support of the Quality Management System for the Mahwah site.
Authority to issue, review and approve documents with administrative oversight of the Document Management Process and Change Control.
Train and educate in the Quality Management System. Create and maintain training matrices and administration of training records associated with the Quality Management System.
Report on a regular basis the status of the Quality Management System via analysis of quality data inputs from QA and other functions as appropriate.
Collect, organize, analyze, and provide data, information, and/or trend reports for management review in a format that clearly communicates the results. Provide feedback data for Post Market Surveillance.
Plan and conduct periodic internal / external quality audits and preparation of documents of report findings and any corrective actions to assure that the quality management system is in compliance with established requirements and to determine its effectiveness.
Support regulatory inspections regarding quality systems.
Provide guidance and/or collaborate routinely with all functions (local & global) to ensure that quality system requirements are maintained and/or will be met.
Support review, analysis, evaluation and corrective actions associated with reported adverse events and customer complaints.
Qualifications
Bachelor’s degree from a four-year College or University in an engineering discipline.
Experience with 21 CFR 110 and 111
Experience with GMP and ISO 9001