Quality System Engineer

The Quality Systems Engineer I supports the administration, monitoring, and continuous improvement of the global QS program across all sites. This role ensures compliance with applicable standards, regulatory requirements, and internal procedures.

• Assist in maintaining and improving the QMS.
• Support compliance with FDA, ISO 9001, 13485, AS9100 and other applicable standards/regulations.
• Participate in document control activities and change control processes.
• Support all types of audits (external and internal).
• Support all phases of Corrective Action and/or Preventive Action (CAPA).
• Track and report on CAPA status.
• Assist, Support and Maintain risk management documentation.
• Support employee training compliance.
• Collect and analyze quality metrics (KPIs).
• Prepare reports on Audit results, CAPA trends, Customer complaints, Process performance.
• Collaborate with Complaint ...