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Sr. Quality and Regulatory Compliance Engineer

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Location
NJ
Job Type
Direct Hire
Date
Jun 22, 2017
Job ID
2495518
Sr. Quality and Regulatory Compliance Engineer
Responsibilities:
  • Assures Regulatory and Quality compliance in the area of verification and validation, design controls, and design transfer engineering for biomaterial products.
  • Contributes to and executes engineering schedules and plans.
  • Supports new product launches in compliance with EMA, FDA, and Notified Body requirements
  • Reviews and approves written reports and engineering documentation as necessary.
  • Executes tactical implementation of strategic plans.
  • Assures compliance with company Standard Operating Procedures and policies.
  • Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards.
  • Reviews and approves engineering test protocols for testing of component parts and integrated systems.
 
Requirements:
  • Ten (10) years’ experience in engineering practice including project development, Quality, Regulatory Affairs or manufacturing responsibility.
  • Bachelor’s Degree in Engineering or another scientific discipline. Master’s degree preferred.
  • Demonstrated experience with European Medicines Agency (EMA) regulation, specifically Annex 1 requirements.
  • Demonstrated experience in an FDA controlled environment (Medical Device, Biotech, and Drug/Medicinal).
  • Demonstrated experience with Design Control / Change Control.
  • Demonstrated experience with Risk Management Practices
  • Demonstrate technical leadership among peers.