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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.
• 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:  
• 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
• 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
• 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
Please reference job # 60478650TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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