ApTask
Responsibilities
Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS platform for health and control processes. Lead Digital QMS audit & inspection readiness, deviations and change control activities. Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS. Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations. Manage and provide oversight of documents / records within the Quality Management System. Oversight of process key performance indicators and metrics. Manage external contractors providing services to the Digital QMS. Work across teams managing priorities. Qualifications
Strong knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards. Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g., FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13945, EU Medical Device Directive, EN 60601 and IEC/EN 62304). Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities; ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs. Proficient working on multiple projects in a deadline driven environment. Strong decision making and organization skills with the ability to prioritize multiple business priorities. Experience in project management, process improvement and quality system management. Effective verbal and written communication skills (writing and presentations) in English. About ApTask
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-owned company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development.
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Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS platform for health and control processes. Lead Digital QMS audit & inspection readiness, deviations and change control activities. Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS. Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations. Manage and provide oversight of documents / records within the Quality Management System. Oversight of process key performance indicators and metrics. Manage external contractors providing services to the Digital QMS. Work across teams managing priorities. Qualifications
Strong knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards. Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g., FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13945, EU Medical Device Directive, EN 60601 and IEC/EN 62304). Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities; ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs. Proficient working on multiple projects in a deadline driven environment. Strong decision making and organization skills with the ability to prioritize multiple business priorities. Experience in project management, process improvement and quality system management. Effective verbal and written communication skills (writing and presentations) in English. About ApTask
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-owned company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development.
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