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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 Stamford, Connecticut with offices in New Jersey, North Carolina, Wisconsin and Florida. For more information please visit www.fujifilmusa.com.
We are hiring for a Data Entry Associate (Internally known as a Quality Systems Associate). In this role you will 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
Ensure timely entry of identified customer complaints into the validated electronic quality management system
Attach supporting documentation into the quality management system to support completed activities
Interact closely with Customer Service, Service, Repair, Quality Assurance, and Regulatory Affairs to facilitate required action
Follow/maintain database spreadsheets to ensure all complaints are addressed within the designated timeframe
Check all completed work for accuracy
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
Associates Degree, Bachelor Degree highly preferred
Experience performing Quality System support activities in a U.S. FDA regulated environment highly desired
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 USA, Inc. offers a fantastic compensation package, including benefits, and a 401k program. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page
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