QMS Intern at ATL Technology · San Rafael

Quality Management System (QMS)

• Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
• Develop, review, and update quality procedures, work instructions, forms, and templates.
• Ensure quality system processes are implemented and consistently followed throughout the organization.
• Support electronic Quality Management System (eQMS) administration and optimization.

Document Control

• Manage document control processes, including creation, revision, approval, release, and archiving of controlled documents.
• Monitor quality records for completeness, accuracy, and compliance.

CAPA Management

• Support root cause investigations using quality tools such as:

             - 5 Whys
  
              -Fishbone Diagrams
  
              -Fault Tree Analysis
  
              -Pareto Analysis
  

• Verify effectiveness of corrective actions and maintain CAPA records.

Nonconformance Management

• Support investigation and resolution of nonconforming materials, products, and processes.
• Analyze quality trends and recommend improvements.

Audit Management

• Participate in:

-Internal audits

-Supplier audits

-External certification audits

-Regulatory inspections

• Prepare audit reports and ensure closure of audit findings.
• Support readiness activities for notified body and regulatory authority inspections.

Risk Management

• Participate in risk assessments and risk reviews.

Training and Compliance

• Ensure employees are trained and qualified on applicable procedures.
• Monitor training effectiveness and compliance metrics.