Global Quality Compliance Director, Medical Devices

Cardinal Health; Northern (KY); On-site; USD 137,000 - 190,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Job summary

Cardinal Health is seeking a seasoned Director of Quality Compliance (Medical Manufacturing) to oversee QMS compliance for the medical device business. You will lead FDA inspections, CAPA governance and audit programs, ensuring readiness for internal, supplier, and regulatory inspections across global operations.

The role requires 10+ years in FDA-regulated quality roles, strong ISO/GMP knowledge, and the ability to drive remediation and organizational change in a fast-paced environment.

Qualifications

• 10+ years of progressive experience in Quality, Compliance, Regulatory Affairs, or related functions within an FDA-regulated industry.
• Demonstrated experience leading and managing FDA inspections, including responses to FDA Form 483 observations and Warning Letters.
• Strong understanding of FDA regulations, ISO standards, GMP requirements, and global quality compliance expectations.
• Proven track record developing and executing remediation plans and CAPA.
• Willingness to travel roughly 25%.

Responsibilities

• Oversees department operations with supervision of managers and professional employees.
• Develops process strategies to improve efficiencies and achieve specific goals.
• Partners with functional leaders on strategic improvements and communication.
• Develops policies and procedures to ensure global QMS complies with regulatory and ISO requirements.
• Leads auditing process and audit teams, including Supplier and Internal Audit programs.
• Implements an inspection readiness and support program to ensure ongoing audit-readiness.
• Supports global R&D activities ensuring proper compliance guidelines.

Skills

FDA inspections

CAPA governance

Regulatory compliance

QMS ISO expertise

Leadership

Audit management

Analytical skills

Communication

Job description

Cardinal Health is seeking a seasoned Director of Quality Compliance (Medical Manufacturing) to oversee QMS compliance for the medical device business. You will lead FDA inspections, CAPA governance and audit programs, ensuring readiness for internal, supplier, and regulatory inspections across global operations.

The role requires 10+ years in FDA-regulated quality roles, strong ISO/GMP knowledge, and the ability to drive remediation and organizational change in a fast-paced environment.