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
- 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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