FUJIFILM

Quality Systems Specialist

Job Locations US-VA-Richmond
Posted Date 4 months ago(1/5/2021 9:55 AM)
Requisition ID
2020-14200
Category
Quality Control
Company (Portal Searching)
FUJIFILM Medical Systems

Overview

FUJIFILM Medical Systems U.S.A., Inc.  is a leading provider of unrivaled diagnostic imaging products and medical informatics solutions that meet the evolving needs of healthcare facilities today and into the future. Medical imaging solutions span digital radiography (DR), detectors, portables and suites, mammography systems with digital breast tomosynthesis, computed tomography solutions for oncology and radiology applications, as well as technologically advanced flexible and surgical endoscopy solutions. Fujifilm enables interoperability through its Systems Integration offering as well as its comprehensive, AI-supported Synapse® Enterprise Imaging portfolio, which includes the TeraMedica Division of Fujifilm. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Lexington, Massachusetts. For more information please visit www.fujifilmhealthcare.com.

 

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. 

External US

Duties and 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.
  • Support Corrective and Preventive Action (CAPA)
  • Support Nonconforming Product activities and the associated investigation.
  • Perform Internal Audits.
  • Review Environmental Data
  • Support the Equipment Calibration program
  • Coordinate U.S. FDA remediation activities.
  • Provide oversight for Relabeling, including QC inspections of the finished product and update or relabeling specifications.
  • Review of batch record
  • Support Management Review Meeting presentations.
  • Attend all department and company-wide team meetings as needed.
  • Other duties as assigned.
  • Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485:2016 standard requirements and all other applicable laws, regulations and standards.

Qualifications

  • Bachelor Degree highly preferred.
  • Previous laboratory experience/manufacturing experience 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).

Physical Requirements

  • The position requires the ability to perform the following physical demands and/or have the listed capabilities:
  • The ability to sit up 75-100% of applicable work time.
  • The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
  • The ability to stand, talk, and hear for 75% of applicable work time.
  • The ability to lift and carry up to ten pounds up to 20% of applicable work time.
  • Close Vision: The ability to see clearly at twenty inches or less.

Travel

Occasional (up to 10%) travel may be required based on business need.

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