Process Engineer

We are currently seeking Process Engineer for a 12 month contract role in Roswell, GA. Individual will be responsible for designing and implementing manufacturing processes which are compliant with FDA/ISO Quality Systems regulations for Medical Devices.

We are looking for someone that is familiar with specific examples on their 510k experience, ability to write protocols and reports independently and have some level of skill with project coordination with cross functional teams to gain approvals.

Skills:

- Bachelor's Degree or 2-5 years of equivalent experience
- Must be familiar with DESIGN CONTROL DOCUMENTATION, PROTOCOL AND REPORT WRITING FOR MEDICAL DEVICES, lead and coordinate activities with external vendors, order product and submit for testing
- Must be familiar with 510K submissions and providing supporting documentation for submissions.
- Must be able to review and analyze test resultsFamiliar with a variety of field concepts, practices, and procedures.
- Relies on experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- At higher levels, may lead and direct the work of others.
- A wide degree of creativity and latitude is expected

Interested candidates please email your Resume