Job Description
Position Summary
This position ensures products meet safety, regulatory, and quality standards throughout the product lifecycle, from design and development to post-market surveillance for medical devices within combination products. Responsibilities include risk management, participation in root cause analyses, process validation, and maintaining Design and Development Files (DDF) related to medical devices.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
Maintain and improve risk management files (ISO 14971) and Design and Development File (ISO 13485).
Review/Approve technical documentation, quality plans, and support new product development and introduction.
Job Details
- Location Zebulon, North Carolina
- Job Type Full-time
- Category Engineers
- Posted Date June 08, 2026
- Application Deadline July 18, 2026