Overview

Salary: $100,000.00 – $120,000.00

Client is seeking a Senior Quality Engineer to join their team.

  • Assures Regulatory and Quality compliance in the area of verification and validation, design controls, and design transfer engineering for Integra’s 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.
  • Prepares verbal presentations for various company meetings

Qualifications:

  • Bachelor’s Degree in Engineering or other scientific discipline. Master’s degree preferred.
  • Ten (10) years’ experience in engineering practice including project development, Quality, Regulatory Affairs or manufacturing responsibility.
  • Demonstrated experience with European Medicines Agency (EMA) regulation, specifically Annex 1 requirements.
  • Demonstrated experience in a 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.
  • Knowledge of engineering documentation.
  • Knowledge of engineering test protocols.
  • Knowledge of design transfer concepts
  • Skills in personal computer spreadsheet, word processor and engineering tools.
  • Ability to carry out engineering calculations and analysis.
  • Ability to review engineering documents, test protocols, laboratory notebook entries and reports.
  • Ability to present verbal reports at company meetings.
  • Ability to review and analyze engineering reports.
  • Ability to participate and represent the Quality function on design / transfer teams
  • Knowledge and understanding of Good Manufacturing Practices and other applicable standards.

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