Senior QA Leader: FDA Compliance & Audit Expert

Veranex; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Veranex is seeking a Senior Manager of Quality Assurance in the United States to lead the QA team, ensure compliance with FDA regulations, and drive continuous improvement across the quality system. The role involves coordinating audits, CAPA processes, and supplier oversight to maintain the highest standards for our development products.

You will collaborate with cross-functional teams, monitor regulatory changes, and implement strategic initiatives to improve quality metrics and inspection

Qualifications

• Bachelor's degree in a science discipline required.
• 7–10 years in healthcare field, preferably with medical device experience.
• Strong, demonstrated understanding of FDA regulations.

Responsibilities

• Develop processes to maintain FDA compliance.
• Lead internal and external audits.
• Monitor regulatory trends and ensure inspection readiness and high-quality results.
• Collaborate with Testing Facility Management and Institutional Official to drive quality changes.
• Communicate regulatory updates to relevant stakeholders.
• Provide vendor oversight to ensure compliance.

Skills

FDA Regulations

QA Leadership

Audit Management

CAPA Management

Training & Docs

Education

Bachelor's degree in science

Tools

MasterControl

Quality Management System

Job description

Veranex is seeking a Senior Manager of Quality Assurance in the United States to lead the QA team, ensure compliance with FDA regulations, and drive continuous improvement across the quality system. The role involves coordinating audits, CAPA processes, and supplier oversight to maintain the highest standards for our development products.

You will collaborate with cross-functional teams, monitor regulatory changes, and implement strategic initiatives to improve quality metrics and inspection