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Medical Device Reporting Specialist/ Entry Biomedical Engineer - 60478650 - TT

Job Code: 60478650
Job Location: Minneapolis, MN
Category: Quality Engineering
Last Updated: 01/25/2018
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Job Description:
We have 20+ openings for our medical client.
POSITION RESPONSIBILITIES:
• Receive and assess product comments to determine need for complaint handling record.
• Document required information in Global Complaint Handling (GCH).
• Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting:  
 
Requirements:
• Must have a Bachelor's degree in Biomedical or Nursing.
• Any complaint handling/customer service is a BIG PLUS.
• Strong documentation or technical writing experience.
• Must have excellent computer skills
BASIC QUALIFICATIONS:
• Bachelor degree- BioMedical Engineering, Health-care or Nursing
• High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
• 0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
PREFERRED QUALIFICATIONS:
• Knowledge of basic anatomy, physiology, and medical terminology
• Knowledge of:
o 21CFR, Section 820, Quality System Regulation
o 21CFR Section 803, Medical Device Reporting
o ISO 13485, Quality Systems, Quality Management Systems
o 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
o (Council Directive 93/42/EEC for Medical Devices)
o PC 1998-783 - Canadian Medical Device Regulation (CMDR)
• Complaint handling experience or customer service/technical support experience (0-2 years)
• Excellent communication skills (oral and written), with strong organizational and analytical skills
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 60478650TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 

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