Senior Quality Control Manager- Healthcare / Medical Packaging

Sr. Quality Control Manager - Healthcare / Medical Packaging

We're actively searching for a seasoned Quality Control Manager to join a fast-paced healthcare and medical packaging organization

In this role, you'll:

Lead and maintain the Quality Management System (QMS) for healthcare and medical packaging products

Drive compliance with ISO 13485, ISO 15378, and FDA cGMP standards

Ensure audit readiness and excellence in all quality processes

Oversee CAPA management, root cause analysis, and corrective actions

Partner closely with suppliers and cross-functional teams to integrate quality into all aspects of the business

Mentor and lead quality team members toward continuous improvement

What we're looking for:

Proven experience in regulated manufacturing (medical device, medical packaging, pharmaceutical, or similar)

Strong leadership and quality systems expertise

Hands-on experience with audits, CAPA, risk management, and supplier quality

Deep knowledge of ISO and FDA regulatory frameworks