Engineering Analyst I

ID# DCNJ27347

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Deals with internal and external customers on product complaints. Works independently with minimal supervision. 

Principal Duties and Responsibilities (essential functions) 

  • Interfaces with external customers, sales representatives and international affiliates. 
  • Manages product complaints using the electronic system CHATS. 
  • Differentiates between product inquiry and product complaint and forwards to respective location for prompt customer service. 
  • Interfaces with electronic systems (e.g. CPAS, COACT, LIMS) 
  • Determines negative trend and enters product complaint into CPAS while identifying corrective/preventive action team. 
  • Makes MDR/MDV decisions for product complaints. 
  • Assists in providing analysis of trends and factors to Operations and technical staff management for resolution. 
  • Utilizes statistical tools to provide technical groups and sales/marketing groups with the appropriate information on field product quality. 
  • Provides timely process and response to external customer for closure or product complaint. 
  • Provides support to Ethicon facilities during audits. 
  • Supports Project Managers or Managers on various projects. 
  • Accountable for all product complaints from inception to closure as well as corrective action follow-up. 
  • Works independently with minimal supervision. 
  • Supports safety and environmental initiatives. 

Education and/or Experience 

  • BA/BS in Scientific, Technical or Engineering field. 
  • BSN in nursing considered. 
  • Desirable knowledge of statistical applications and auditing practices. 
  • Technical background needed (systems, software programs, research) 
  • Preferred Industry Medical Devices/diagnostics and/or other regulated industry. 

Other Skills and Abilities 

  • Competency in MDR and Vigilance regulations, medical knowledge, liability law, product use, product complaint and inquiry processes, submission practices. 
  • General competency in QSR/ISO knowledge 
  • Product/process knowledge 
  • Good written/ oral communications skills and good computer skills, 
  • Customer service oriented 
  • Knowledge in existing quality systems 
  • Ability to handle multiple priorities 
  • Respect confidentiality.

Position Details:

Medical Device

Engineering

Start Date: 
9-30-2013
End Date: 
9-1-2014

SOMERVILLE, NJ

CON_W2

40

DCNJ27347

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