Full-Time Quality/Regulatory Engineer (Medical Device)

We are expanding our Quality Assurance Team and are actively looking for a
Full-Time Quality/Regulatory Engineer (Medical Device).  Apply today!  Excellent pay and benefits!

About Our Company:

We are a Service Disabled Veteran Owned Small Business headquartered in Dover, New Hampshire, with 30 years of experience specializing in the design, development, manufacture, and sales of diagnostic and rehabilitative medical devices.

Supervision Received:

  • Individual will report to the Quality/Regulatory Manager

Essential Duties and Responsibilities:

  • Assist the Quality/Regulatory Manager to ensure that medical devices are in compliance with applicable regulatory requirements and quality standards from the concept stage through the post-market stage
  • Assist the Quality/Regulatory Manager with the following:
    • Verification and Validation Activities
    • Risk Management
    • Design Control
    • Design Change Assessment
    • Registration of products with foreign countries
    • Preparation for Regulatory Audits

 Required Qualifications:

  • Familiarity with IEC 60601 Standards
  • Familiarity with FDA Requirements for Medical Devices
  • Familiarity with ISO 13485:2016 Standard
  • Must have outstanding communication skills (verbal and written)
  • Must be an outstanding team member
  • Must be able to multitask
  • Must be able to work with outside Engineering and Regulatory consultants

Other Helpful Qualifications:

  • Experience with European Union CE Marking Requirements
  • Experience with the Medical Device Single Audit Program (MDSAP) and familiar with regulations of participating countries
  • Experience with UDI Requirements
  • Experience working in a high energy, fast paced environment
  • Experience working in a small business

Employment Type: Full-Time

To apply, please send your cover letter and resume to career@theprogrp.com.

 

 

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