JOB TITLE:  Medical Regulatory Compliance R&D Quality Engineer

REQUIRED SKILLS

A.  Bachelor’s Degree preferred

B. 3 – 7 years medical device experience working on R&D projects

C.  Strong working knowledge of Quality System experience; ISO and FDA regulatory experience

D. Design controlled R&D projects  for medical devices.

DESIRED SKILLS

1. ISO (QSM) quality management systems certification
2. Electrosurgical generator experience
3. Analysis of IEC 60601-1 (or similar) to product design, 60601-2-2 preferred

Additional information:

Provide quality engineering support for medical device development projects

Conduct risk management and develop FMEAs/FTAs for product

Assist in the development of test procedures and design validations

Develop traceability matrices

Assist in IQ/OQ/PQ development and design transfer activities

Testing and other duties as assigned