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Drive controls system hardware selection and implementation to create functionally safe systems capable of achieving SIL levels dictated by assessments as confirmed by SISTEMA. 5 Support the structuring, development, integration, and maintenance of a digitally integrated manufacturing facility included but not limited to SCADA, SDMS, LIMS, MES, BAS, QMS, data historians/storage, or other digital software solutions.
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Proficient with the TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system). As a Quality System Manager in the pharmaceutical industry, your primary responsibility will be to develop and maintain an effective quality management system (QMS) to ensure compliance with pharmaceutical regulatory requirements and industry standards.
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Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits. 1-3 years of QA or five years of GxP regulated (GLP, GMP, GCP) industry experience; We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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Follow all company policies, cGMP, Food Safety, FDA, USDA, GFSI, FSMA, OHSA Safety regulations, QMS and SOP / SSOPs∯*∯ The QA Technician will support the implementation and enforcement of the Quality and Food Safety Management System requirements throughout all of the manufacturing process in order to ensure compliance with the company policies, FDA cGMP, and industry standards.
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Analyze and report out at monthly operations review on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement. This position reports to the VP of Manufacturing and serves in a vital role supporting efforts of the Supply Chain, Operations, and Engineering organizations.
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Maintain an effective quality management system (QMS) to ensure the consistent delivery of high-quality products. Overseeing Vigilance and Post-Market Surveillance activities. General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
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Job Summary: Champion the design, implementation, and coordination of robust QMS programs for assigned plants, guaranteeing adherence to contractual requirements, industry standards, and best practices through continuous quality surveillance.
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Establish and monitor quality objectives, metrics, and key performance indicators (KPIs) to evaluate the effectiveness of the QMS. Stay abreast of regulatory changes, industry best practices, and technological advancements in the field, and update the QMS accordingly.
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Audit manufacturing and QMS processes. Prepare AIAG PPAP's and FAI packages including dimensional inspection reports, PFMEAs, control plans and process flow diagrams. Working knowledge of ASME Y14.5M GD&T interpretation and application.
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The Sr. Quality Engineer will be primarily focused on supporting new product development as well as supporting general sustaining activities while maintaining the effectiveness of the overall QMS. This position will support new product development and sustaining activities related to Vapotherm’s complete product portfolio with focus on both hardware and disposable products.
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Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.
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Ensures operational compliance with the clinical laboratory’s Quality Management Systems (QMS) Program and delivering the routine QMS associated metrics. Participates in the monthly QMS meetings, presenting activities and metric outcomes to review and assess compliance, developing and implementing remedial activity plans, as needed, and activities for quality improvement.
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Supports the QMS by adhering to the system requirements. Detailed knowledge in PLC programming and electrical controls, as applicable. Perform maintenance task such as interfacing with the process control team and react to urgent requests that could impact production.
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In charge of HIPArelated activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructions. Responsible for the management of the Regulatory Affairs Processes, Registration, Non-Conformities, Product Recalls, and Medical Device Reporting (EUMDR.
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Summary of PositionThe Sr. Quality Engineer will be primarily focused on supporting new product development as well as supporting general sustaining activities while maintaining the effectiveness of the overall QMS. This position will support new product development and sustaining activities related to Vapotherm’s complete product portfolio with focus on both hardware and disposable products.
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