FUJIFILM

Manager, Quality Management Systems

Job Locations US-MA-Lexington
Posted Date 4 months ago(1/5/2021 9:57 AM)
Requisition ID
2021-14214
Category
Quality Assurance
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.

 

Job purpose

This position is intended to manage the day-to-day Quality Management Systems department activities for FUJIFILM Medical Systems U.S.A., Inc. (FMSU). This position is intended to maintain 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

  • Manage and maintain full 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.
  • Manage, train, develop and oversee the Quality Management System department staff and all related activities.
  • Manage the department (staff, tools, processes and workflow) and optimize for maximize productivity and compliance.
  • Capture monthly metrics (Key Performance Indicators), perform trending and ensure that metrics and trends meet department goals and objectives.
  • Collaborate with other FMSU business sites and FUJIFILM business entities to achieve department goals and objectives.
  • Perform day-to-day Quality Management System activities (Complaint Processing, Supplier Management, Nonconforming Material/Product, Equipment Management, CAPA, Statistical Analysis, etc.).
  • 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 standard requirements and all other applicable laws, regulations and standards.

Qualifications

  • Bachelor’s Degree highly preferred.
  • Five (5) or more years of experience managing Quality Management Systems and the associated department staff in a regulated medical device company.
  • Five (5) or more years of hands on experience performing Quality Management System activities in a U.S. FDA and ISO 13485 medical device regulated environment.
  • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806 and 21 CFR 807) and international standard requirements (ISO 13485/ISO9001, ISO 14971, IEC 62304 and the Medical Device Directive) 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.

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 25%) travel may be required based on business need.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed