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MDR/ Biomedical Engineer - 61754409 - TT

Job Code: 61754409
Job Location: Mounds View, MN
Category: Quality Engineering
Last Updated: 08/29/2018
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Job Description:
We have an opening for a Biomedical Engineer with Medical Device Reporting experience.  
POSITION DESCRIPTION:
This position provides communication and follow-up to customers and field sales force regarding the analysis results of customer complaints for products. Communicates event investigation results via regulatory reports and written communications, as appropriate.  
This process is governed by the FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices (GMPs), and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations.
This position requires the individual to be a main contributor to product quality improvement efforts and be the main contact to our customers on complaint issues.
In addition, this position will analyze customer complaints to determine which are regulatory reportable, will generate and submit the regulatory reports within the government mandated timelines, and is a key contact for activities with internal, field, and end user customers.  
POSITION RESPONSIBILITIES:
• Facilitates complaint communications and assess for regulatory reportability and potential impact to patient safety and business operations.
• Completes and submits regulatory reports within the time frames mandated by the FDA.
• Solid knowledge in clinical settings related to product application. Evaluates identified complaints. Investigate complaints.
• Receive and document product events reported by customers and field representatives. Request additional information as needed for complete understanding of the event.
Determine if event is a product complaint.
• Enter all information related to the events into the complaint database. Maintain files that meet the QSR and Corporate requirements.
• Routinely analyze and evaluate work processes to improve work processes and service to customers.
 
Requirements:
REQUIRED EDUCATION:
• Bachelor’s Degree in Biomedical Engineering or BS Nursing
The top 3 requirements:
1. MDR vigilance experience (3months or more)
2. Experience working with Medical devices
3. Previous quality experience  
DESIRED/PREFERRED QUALIFICATIONS (optional)
• Clinical and/or regulatory background. • Solid knowledge of word processing, spreadsheet, database and graphics presentation applications.
• Solid oral and written communication skills
• Record management • RN, CNP, or Biomedical Engineer
• Solid knowledge of worldwide adverse event reporting requirements (21 CFR 803, QSR 820, MEDDEV 2.12-1, Article 253 of Pharmaceutical Affairs Law, etc.). •
 
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 # 61754409TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 

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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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