Job Number: 20015535

Locations:
El Paso, TX
San Diego, CA
Miami, FL

Date Posted: 5-16-2017

Job Title: Director, Quality Assurance Operations

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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

  • Lead QA personnel supporting manufacturing operations in 5+ Medical Device manufacturing sites throughout Latin America
  • 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

Qualifications

  • Bachelors and Advanced degree in related field, or equivalent work experience, preferred
  • 15+ years minimum of Medical Device manufacturing experience in functions such as QA, RA, Compliance, Operations, OpEx, Manufacturing, Supply Chain
  • 5+ years of experience working in and managing employees in Mexico, Costa Rica or other LATAM countries
  • 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
  • Experience in product manufacturing transfers, facility/line startup, etc.
  • Bilingual fluency in English and Spanish required
  • Ability to travel up to 40%

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

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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