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Summary

The Quality Systems II Engineer is responsible for supporting the site Quality Management System (QMS). Primary responsibilities include driving improvements to the QMS, having oversight of and ensuring compliance to the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. This role will provide training on QMS processes to the organization, champion the QMS and work on many phases or sub-tasks of projects or entire projects.

Supervision Received

This position is under the direct supervision of the Quality Engineering Manager. Works independently under general supervision,



reviewed at project milestone and/or completion by senior management.

Essential Duties and Responsibilities
- Supports maintenance of the Quality management System, ensuring compliance with regulations and internal site and general procedures. Identifies gaps in the QMS and drives improvements to close gaps.
- Maintains the Quality Manual and site Quality System related procedures, ensuring contents are compliant and appropriate for the business.
- Identifies Nonconformities, works with complaint handling, and CAPA Investigations.
- Organizes and manages the plant internal audit system as the site Internal Audit Manager.
- Supports external Quality System audits in key roles. Provides support and subject matter expertise during audits and inspections.
- Assists in the initiation, processing, and completion of CAPA records in the electronic system.
- Leads meetings and communications for CAPA updates, information, and concerns

📌 Quality Systems II Engineer (Galicia)
🏢 Integra Lifesciences
📍 Galicia