At Cardinal Health, we are developing the innovative products and services that make healthcare safer and more productive. This is your opportunity to join a growing, global company genuinely committed to making a difference to our customers and communities.
The Manufacturing Quality Director will be responsible for leading Quality personnel supporting manufacturing operations of multiple Medical Device manufacturing sites (6+) throughout North America in the Southeast. In this role, individual must provide effective people leadership to direct reports and sub-reports within the Quality division.
Accountabilities: - Leading QA personnel supporting manufacturing operations of multiple Medical Device manufacturing sites (6+) throughout North America
- Management of ~5 direct reports (site Quality Managers) with total team size ~50.
- Ensures manufacturing activities are in accordance to the quality system and in compliance to all applicable regulatory requirements
- Develops and implements strategies to continuously improve quality system processes, reduce defects and ensure the highest quality products for our customers
- Budgeting, planning and resource evaluation
- Participate with production management to define and support goals outlined in the companyperating plan
- Key performance indicator monitoring and reporting
- Interface with internal constituents and external regulatory bodies regarding compliance needs
- Interface with customers to resolve problems related to products manufactured
Qualifications - Bacheloregree required; relevant graduate degree preferred
- 10+ years minimum FDA regulated industry experience in functions such as Quality, Regulatory Compliance, Operations, Operational Excellence, Manufacturing.
- Medical Device industry preferred
- 5+ years managing people
- Strong leadership skills with ability to prioritize and deliver on multiple concurrent initiatives that have significant financial and strategic impact
- Experience in leading and managing internal and external compliance audits. (FDA, ISO, etc)
- Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulations
- Experience in product manufacturing transfers, facility/line startup, validation, etc.
- Ability to travel 50%
