Service and Repair QA Manager

What Quality Engineering contributes to Cardinal Health

The Global Quality Assurance Service and Repair Manager ensures medical device service and repair activities are consistent, compliant, and effective for our products.   The role will oversee quality activities related to both internal and external service and repair practices as well as supporting regional resources in Asia/EU/LATAM.   Related quality systems policy and procedures, day-to-day tactical process / product issues, quality metrics/reporting and involvement in long term strategic initiatives will all be responsibilities of the role. Work is performed with minimal direction.  Develops solutions to complex problems, which require regular use of ingenuity, innovation and sound decision making.

Accountibilities

  • Ownership of quality system procedures and policies related to service and repair
  • Co-ordinate & monitor all Quality KPI’s for related to service and repair activity including any service providers.
  • Identify and lead improvement initiatives where required to achieve KPI targets.
  • Lead/Support quality improvement projects to ensure consist, efficient and compliant service
  • Utilize benchmarking of best in class processes to provide information for continuous improvement.
  • Conduct or participate as needed in internal audits. 
  • Supports service and repair processes in external audits.

Qualifications

  • Education:  BS or MS in Electrical, Mechanical, Industrial or Manufacturing Engineering, or related field
  • Minimum of 5 years of experience in a Manufacturing, Quality or Regulatory role within the medical device industry.
  • Certified quality engineer/reliability engineer , preferred
  • Knowledge of ISO13486, 14971, Quality System Standards and FDA Quality System Regulation

  • Knowledge of risk management (FMEAs), statistical process control, and statistical sampling plans is desirable.
  • Strong technical writing abilities.
  • Strong verbal/written skills 

What is expected of you and others at this level?

  • Communication: Ability to communicate effectively in multi-discipline environment, and across cultures and levels of organizations
  • Project Management: Ability to organize and manage multiple priorities and teams.
  • Organizational Management: Ability to directly manage teams and individuals to achieve high levels of performance.