This position is intended to provide Quality System support to FUJIFILM Medical Systems U.S.A., Inc. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.
Role and Primary Responsibilities:
Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
Coordinate all Mandatory Field Notifications and Engineering Change Orders, take appropriate action and maintain all records
Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action
Perform Corrective and Preventive Action and Nonconforming Product activities
Perform Internal Audits and External Supplier Audits
Coordinate U.S. FDA remediation activities
Prepare Management Review Meeting presentations
Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards
Attend all department and company-wide team meetings as needed
Other duties as assigned
This position description contains the general duties considered necessary to outline the principal functions of the job and shall not be construed as inclusive of all work requirements which may be inherent to successful performance.
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.
Three (3) or more years of hands on experience performing Quality System support activities in a U.S. FDA regulated environment
Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)
Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations)
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
Internal Number: 2019-3550
About Fujifilm Medical Systems USA, Inc.
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 superior 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.