Skills & Experience Required:
- Must possess knowledge of domestic (FDA) & foreign regulatory requirements for the manufacture & distribution
- of medical devices (especially design control & technical file compilation).
- Must have knowledge of Microsoft Office: (Word, Excel, Access & PowerPoint.)
- Meet deadlines prioritize work take the initiative to follow-up on unresolved issues, complete assigned tasks, handle multiple tasks, & work independently.
- BS or BE in a relevant science or engineering discipline with 3-5 years’ experience in regulated industry.
NESC Staffing Corp is seeking a QA/ RA Specialist Position to work in one of their medical manufacturing industry:
· support new product development & renovate the on-market product development documentation in
· position with the latest regulatory requirements.
· Focus on enhancement of the technical files & risk management
· documentation including revising product/manufacturing process changes, supplier changes, new & revised
· engineering protocols & reports & reviewing product labeling. Guarantee compliance with the design control
· process & with the Quality Management System.
· The position will work closely with the R&D/Engineering group as well as QA/RA.