Principal Quality Engineer
My client is a Top Ten medical device company whose products span the spectrum of healthcare, ranging from diabetes management to COVID diagnostics. Given their success in the past year, they are looking to expand their team by adding a Principal Quality Engineer to their rapid diagnostics team. You would be a cross functional member of the quality team in order to help provide guidance and support throughout the product's life cycle.
- Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management.
- Review new and modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.
- Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes with software and hardware development.
- Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
- Bachelor's degree (B.S.) in a Science related field, or equivalent combination of education and experience
- 5+ years of experience in a Quality and/or Development Position
- Significant experience and knowledge of the following regulations: ISO 13485, ISO 14971, IEC 62304, 21 CFR 820.30
- Preferred - knowledge of FDA inspections and quality investigations
Don't hesitate to apply if you're ready for the next step in your career!