Quality Specialist

Massachusetts  ‐ Onsite
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Keywords

Description

Quality Specialist 

Organization Description: 

  • We simplify healthcare by focusing on the people in the care cycle - patients and care providers.
  • Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system.
  • Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.
  • Some product highlights: 256-slice Brilliance iCT scanner, Integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, Philips Lifeline's personal emergency alert service.
  • Our department provides quality and regulatory function for the Emergency Care Solutions business within Therapeutic Care. 

Responsibilities: 

  • Assist with complaint investigations in accordance with internal and external (FDA, Canadian and European) regulatory requirements. 
  • Coordinate complaint investigation communication and general information gathering. 
  • Investigates customer complaints related to product quality and patient safety 
  • Identify potential safety problems. 
  • Support the investigation of complex clinical and technical issues. 
  • Utilizing product knowledge, verify a reported problem and if necessary get the appropriate product specialist or Engineer involved to verify the problem and document root cause. 

Profile: 

  • Requires strong written, oral and interpersonal skills. 
  • Plans, organizes, and prioritizes own work routine to meet established schedule and support the activities of Q&R. 
  • Proficient computer skills in Microsoft Office applications 
  • Experience investigating device malfunctions or customer problems is preferred 
  • Strong analytical and problem solving skills. 
  • Previous experience in a medical device company preferred 
  • Previous experience with FDA medical device regulations, safety standards and regulatory compliance guidelines preferred. 
  • Complaint handling experience preferred 
  • College degree preferred, but not required
Start date
ASAP
Duration
Over 4 months
From
Software Specialists
Published at
01.06.2014
Project ID:
714676
Contract type
Freelance
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