Description
Educational Requirements:Knowledge of regulations and standards affecting IVDs and Biologics.
Ph.D. in a life or physical science;
Or M.S. with 2+ years relevant experience. Or B.S. in a life or physical science with 4+ years related lab/industrial experience
Special Skills Needed:
Read and understand customer and product requirements.
Work in a team environment to author V&V protocols using peer review process.
Design and conduct studies to validate performance characteristics of products.
Review and analyze performance data and create review summary of tests.
Conduct technical reviews of test data and create verification and validation summary documents.
Familiarity with regulatory and ISO requirements is a plus.
SKILLS REQUIRED:
5-7 years relevant Medical Device V&V experience in an FDA-regulated. Extensive knowledge and experience in biological and diagnostics systems
Customer focused; Excellent oral, written communication and interpersonal skills
Excellent written communication skills; the ability to articulate complex technical concepts and issues in a simple, easy to understand manner.
Must be able to interact effectively and work well with team members under stressful conditions.
*Able to work flexible hours on day and evening shifts
To find out more about Real please visit www.realstaffing.com