Sr. Quality Systems Manager

Manage 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.

REQUIREMENTS

• Bachelor's degree in life sciences or related field preferred
• 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma
• 5+ years in Quality or Regulatory Affairs
• 3+ years managing staff
• Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
• Experienced in supporting NC/CAPA and audit responses