Senior Quality Engineer

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.