FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the Synapse® brand of PACS, 3D, VNA, RIS and CV (cardiovascular products), to advanced women’s health imaging systems, Fujifilm has products that are ideal for any size imaging environment. The Endoscopy Division of FUJIFILM Medical Systems U.S.A., Inc. supplies high quality, technologically advanced FUJINON brand endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT with offices in the Raleigh, NC region. For more information please visit www.fujimed.com and www.fujifilmendoscopy.com
FUJIFILM Medical Systems U.S.A Inc. is currently looking to hire an experienced document management professional to fill a Director, Document Management role. This position will oversee the review, approval, deployment and maintenance of common, top-level Quality Management System documents for all of FUJIFILM Medical Systems USA sites. In addition, this role will partner with internal and external stakeholders to ensure that all top-level Quality Management System documentation is approved and available for use at all sites. Responsibilities will include but not be limited to:
Oversee the effective and efficient review, approval, deployment and maintenance of all top-level Quality Management System documentation
Ensure the effective deployment of Documentation Management and Quality Management System tools/platforms to enable top-level Quality Management System documentation access and use at all sites
Oversee and manage site Documentation Specialists/Coordinators to ensure the effective and efficient deployment of site specific Quality Management System documentation and their associated training
Attend all U.S. Food and Drug Administration (FDA), Notified Body and Global Regulatory Agency inspections and assessments and drive all identified Document Management System related deficiencies to resolution
Continuously assess Document Management and Quality Management Systems tools/platforms and provide recommendations for improvement
Collaborate with other Regulatory, Quality, Compliance and Business Leaders to ensure the implementation of a world-class and fully compliant Document Management and Quality Management System
Attend department and company-wide team meetings as needed
Bachelor Degree highly preferred
Five (5) or more years of experience developing, deploying and maintaining electronic Document Management and electronic Quality Management System solutions (EtQ Reliance, Master Control, Pilgrim, Agile, etc.) in a regulated environment highly desired
Knowledge of U.S. FDA medical device regulations (21 CFR 11, 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 and U.S. FDA submissions) and international standard and submission requirements (ISO 13485/ISO9001, ISO 14971, Medical Device Directive and Product CE Marking) highly desired
Excellent leadership, communication, collaboration, team work and interpersonal skills
Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
Excellent computer and internet search skills
Strong ability to multi-task and to meet business deadlines
Excellent organizational skills with an ability to think proactively and prioritize work
The Company is an equal opportunity employer and does not discriminate, nor allow any employee, customer, contractor, vendor or visitor to discriminate, against any employee or applicant for employment on the basis of race, color, creed religion, sex (including pregnancy), gender, national origin, ancestry, ethnicity, age, genetic information, marital status, disability, sexual orientation, military status (including disabled veterans, recently separated veterans, other protected veterans and Armed Forces service medal veterans), protected activity (such as opposition to prohibited discrimination or participation in proceedings covered by anti-discrimination statutes) or any other characteristic protected by applicable federal, state or local law.
FUJIFILM Medical Systems U.S.A., Inc. (Fujifilm) is a leading provider of medical image and information products and technologies for acquiring, processing, managing and storing diagnostic images and related data. As the inventor of digital x-ray, over thirty years ago with our Computed Radiography (CR) technology, we have built a reputation as an innovator of healthcare systems that produce super...ior diagnostic information. As the healthcare segment evolves, we will continue to provide the market with innovative solutions that reach well beyond general radiography.
Not only are we the leader in digital x-ray systems with our CR and DR (Digital Radiography) based technologies; we are also the global leader in digital mammography. Our leading position in image acquisition is complimented by our ability to offer one of the most comprehensive lines of RIS/PACS solutions, featuring our Synapse® brand of PACS for radiology and cardiology, Synapse® RIS, Synapse® 3D, and Synapse® Mobility applications. Along with our point-of-care ultrasound product, Fazone CB and our endoscopy division's FUJINON brand of endoscopes, Fujifilm offers one of the most diverse product portfolios in the healthcare segment.
Fujifilm Medical's corporate headquarters is located in Stamford, CT providing sales, service, applications, and marketing leadership for its US based operations. The Stamford headquarters also serves as the worldwide R&D center for our medical informatics systems. Fujifilm and its team of renowned engineers are steadfast in their commitment to continuously innovate our product lines in order to provide users with the best quality and highest productivity imaging and informatics solutions to meet their varying needs. Along with our visionary product roadmap and our dedication to providing the ultimate customer experience, Fujifilm is well positioned to help our current and future customers navigate the challenging and dynamic healthcare landscape now and into the future.
Fujifilm Medical Systems, U.S.A., Inc. is a wholly owned U.S. subsidiary of FUJIFILM Holdings America Corporation.