| Location | Gainesville, FL |
This role manages a team of 7 that manages overall quality processes an interfaces with the other departments that are responsible for execution of the quality activities.Must haves:Direct management experienceQuality background in medical devices, pharma, or similar regulated industry.Willing to work on-site (no hybrid or remote) dailyUS Citz/Perm Resident status only
CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATIONManage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity. REQUIREMENTSBachelor's degree in life sciences or related field preferred10+ years' experience in a regulated industry, preferably Medical Devices or Pharma5+ years in Quality or Regulatory Affairs3+ years managing staffExperience with FDA Part 820, Part 1271, ISO 13485, or AATB standardsExperienced in supporting NC/CAPA and audit responses