This job is posted on behalf of Gallin Associates by Top Echelon.
CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION
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
