Manager Quality Assurance, Audit Sterilization/Micro
Core
Managing quality and regulatory compliance for medical device and drug products, leading internal and supplier audits, and overseeing the audit team.
Role type
Manager, Quality Assurance and Audit
Builds
Compliance for sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements
Domain
Medical Device / Pharmaceutical / Regulatory Compliance
Deliverable
client delivery
Required skills
Internal and supplier auditing, CAPA/SCAR management, regulatory standards knowledge (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR), team leadership, project coordination, data analysis
Preferred skills
Supervisory experience in Quality or Regulatory Affairs, Sterilization or Microbiology focus
Technologies
Microsoft Excel, Smartsheets
Responsibilities
Lead internal and supplier audits against FDA/ISO requirements, manage CAPA and SCAR documentation, mentor auditors and conduct training, oversee audit team metrics and schedule, execute continuous improvement projects, hire and manage staff
Seniority
Manager, hands-on leadership