Coordinate, implement and support activities related to the successful overall management of the following quality systems to the requirements of ISO 13485, ISO 9001, and ISO 17025:Internal AuditsExternal Audits (Customer and Supplier)Change ControlCAPA Events / NonconformancesCustomer ComplaintsSupplier Quality SystemRaw Material AcceptanceProduct ReleaseTrainingMasterControl Implementation Assist in the development, implementation and maintenance of quality systems, projects and initiatives that support departmental and company objectives while ensuring compliance to applicable standardsSupport the compilation and analysis of data and overall trending of the quality systems, including Key Performance MetricsSupport investigation activities with regard to OOS failures, CAPA Events and Customer ComplaintsSupport additional quality systems and functional areas including Preventive/Unscheduled Maintenance, Calibration, Validation, Training, Quality Control, and Regulatory Assurance.

Coordinate, implement and support activities related to the successful overall management of the following quality systems:Internal AuditsExternal Audits (Customer and Supplier)Change ControlCAPA Events / NonconformancesCustomer ComplaintsSupplier Quality SystemProduct ReleaseAssist in the development, implementation and maintenance of quality systems, projects and initiatives that support departmental and company objectives while ensuring compliance to applicable standardsSupport the compilation and analysis of data and overall trending of the quality systems, including Key Performance MetricsSupport investigation activities with regard to OOS failures, CAPA Events and Customer ComplaintsSupport additional quality systems and functional areas as needed and/or assigned including, but not limited to Preventive/Unscheduled Maintenance, Calibration, Validation, Training, Quality Control, and Regulatory Assurance.Support special company and corporate initiatives and projects as needed.

Coordinate, implement and support activities related to the successful overall management of the following quality systems: Internal Audits External Audits (Customer and Supplier) Change Control CAPA Events / Nonconformances Customer Complaints Supplier Quality SystemAssist in the development, implementation and maintenance of quality systems, projects and initiatives that support departmental and company objectives while ensuring compliance to applicable standardsSupport the compilation and analysis of data and overall trending of the quality systems, including Key Performance MetricsSupport investigation activities with regard to OOS failures, CAPA Events and Customer ComplaintsSupport additional quality systems and functional areas as needed and/or assigned including, but not limited to Preventive/Unscheduled Maintenance, Calibration, Validation, Training, Quality Control, and Regulatory Assurance.Support special company and corporate initiatives and projects as needed.

Detailed inspection and approval of internal and client documents and their compliance with customer specifications and requirementsDetailed inspection and verification of documents and procedures to ensure internal quality complianceManagement and delegation of special projects within the departmentMaintenance of Calibration schedule for facility, management of Third Party Calibration Company as well as review and approval of resulting calibration documentationAssisting in the investigation, resolution and response to Customer ComplaintsEvaluation of and support for Change Control processesDevelopment and maintenance of quality databases (Document Control, Complaints, Internal Nonconformances, Vendor Nonconformances, Calibration)Creation/Revision and approval of quality procedures, deviations and changesLeading Vendor Nonconformance and Quality Hold programsAssisting Quality Director and other management in compilation of facility metrics and regular quality reporting (e.g., Cost of Quality, Internal Nonconformance and Complaint trending)Development and implementation of Training plans for Quality TechniciansManagement of sample retention programEvaluation of nonconforming product and participation in MRB activitiesReporting and assisting in the investigation of nonconforming productVerification of product requirements and preparation/authorization of shipments via certificate generation for all product shipmentsManagement of Quality lab schedule including production support scheduling and leave coverageClose interaction with Quality and Production ManagementAuthorized backup for Quality Director

Assisting Quality Technicians with quality oversight of production floor including the final approval of all product (including rework)Assistance with Supplier and Material Qualification programsVerification that product conforms to internal and external specifications (set-up, in process and final release) through visual and technical inspections or review of Quality Technician output (2nd approval)Ensuring GMPs are followed for all quality and production processes and documentationReview, approval and maintenance of production batch recordsIncoming material inspection and program managementParticipation in Safety Action Team and Safety Auditing

Ensuring quality and accuracy of all materials run on press while maintaining production quotas Actively troubleshooting machine and materials to ensure qualityPreparation and verification of set-up and in process samples in conjunction with Quality TechniciansReporting all issues to Quality Technician to ensure proper handling of any possible defective or questionable materialAssistance in nonconforming product and complaint investigationsEnsuring compliance with specifications for each job, including line clearance procedures and appropriate safety precautionsParticipation in raw material inventory monitoring for the departmentCompletion, review and approval of various production documentation including controlled documentation, batch records, specifications, etc. for the departmentEnsuring department is compliant with all applicable procedures and specificationsManage activities of helpers and pre-press associates

Review and compliance with applicable work instructions and specificationsVerification of material availability and useMaintenance of raw materials including in process testing as neededOversee activities of helpers and pre-press associates as instructedAssist Lead Press Operator as needed

Setup and operation of various conversion equipment safely and efficiently and in accordance with applicable work instructions and specificationsUtilization of physical/dimensional testing equipment for set-up, in process and final product testing (e.g., digital micrometers, digital calipers, scales)Completion of all required documentation per GMP standards, specification and work instructions