Senior QA Lead : Dallas, TX
10/12/2016 2:56:10 AM
Senior QA Lead
Minimum 5+ years' Quality and Regulatory experience managing departments programs subject to FDA / ISO / CE Mark regulatory requirements. Must have strong experience from the medical device arena.
Direct experience developing and managing a team ideal
Direct experience with hosting/guiding audits from regulatory authorities
Direct experience leading FDA submissions and CE audits
Direct experience with CAPA/Complaint Handling/Internal Auditing
Excellent documentation, communication, and organizational skills
Excellent Critical Thinking skills and ability to adapt to a constantly changing and rapidly growing environment.
Education: Bachelor's preferred.