Job Summary: Lead corporate-wide Quality Systems programs, driving compliance with applicable regulatory standards while managing audits, document control, and continuous improvement across the quality management system.
REQUIREMENTS
- Bachelor's degree in life sciences or related field preferred
- 5+ years in Quality or Regulatory Affairs
- 3+ years leading teams
- Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
- Experienced in supporting NC/CAPA and audit responses
- Experienced driving process improvement initiatives
- Strong communicator with QMS software and process improvement skills