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
Bachelor Degree highly preferred
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
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.
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. FUJIFILM Medical Systems U.S.A., Inc. also supplies high quality, technologically advanced endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts with offices in New Jersey, North Carolina, Wisconsin and Florida. For more information please visit www.fujifilmusa.com.