Manager Quality Internal Audit QMS
Core
Managing quality and compliance for medical device and pharmaceutical products through internal and supplier audits, ensuring adherence to FDA and ISO regulations.
Role type
Manager, Quality Internal Audit (QMS)
Builds
Compliance assurance for sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
Domain
Medical device and pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Internal and supplier auditing, FDA regulations (21 CFR 820, 210/211), ISO 13485, process validation, method validation, sterilization processes, CAPA management, team leadership, project coordination
Preferred skills
Supervisory/managerial experience in Quality or Regulatory Affairs, auditing experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries
Technologies
Microsoft Excel (pivot tables, AVERAGE function)
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 schedules, drive continuous improvement projects, hire and manage staff
Seniority
Manager, hands-on leadership