Director, Quality Assurance Operations

What QRA Management contributes to Cardinal Health

QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.

Accountabilities in this role

  • Role will lead QA Operations in 4+ Medical Device manufacturing sites throughout US and Mexico.
  • Interact with external customers and internal stakeholders on quality related topics
  • Budgeting, planning and resource evaluation
  • Meet with production management on regular basis and support goals outlined in the company’s operating plan
  • Develop strategies to implement Quality system regulations and continuously improve Quality processes
  • Interface with internal constituents and external regulatory bodies regarding compliance needs
  • Define, communicate and enforce quality policies with particular emphasis on compliance to the company’s Quality System and external regulatory standards
  • Spanish fluency preferred
  • Able to travel up to 25%


  • Bachelors and Advanced degree in related field, or equivalent work experience, preferred
  • 10+ years minimum of Medical Device manufacturing experience in functions such as QA, RA, Compliance, Operations, Operational Excellence, Manufacturing, Supply Chain
  • 5+ years of experience managing employees
  • Experience managing external Regulatory Agency compliance audits (FDA, ISO, etc)
  • Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulations
  • Strong interpersonal skills and experience interacting directly with customers

What is expected of you and others at this level

  • Provides leadership to managers and experienced professional staff may also manage front line supervisors
  • Manages an organizational budget
  • Develops and implements policies and procedures to achieve organizational goals
  • Assists in the development of functional strategy
  • Decisions have an extended impact on work processes, outcomes, and customers
  • Interacts with internal and/or external leaders, including senior management
  • Persuades others into agreement in sensitive situations while maintaining positive relationships