Quality Manager, CAPA/CAB

What Quality System Management contributes to Cardinal Health

Quality Systems Management is responsible for the development, deployment and maintenance of controlled documentation and supporting systems.

  • Demonstrates knowledge of quality systems.
  • Demonstrates a thorough understanding of the relevant regulations, standards and operating procedures.
  • Demonstrates an understanding of quality concepts such as: documentation systems, change control and electronic records.
  • Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 8+ years experience in related field, preferred

What is expected of you and others at this level

  • Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
  • Participates in the development of policies and procedures to achieve specific goals
  • Ensures employees operate within guidelines
  • Decisions have a short term impact on work processes, outcomes, and customers
  • Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
  • Interactions normally involves resolution of issues related to operations and/or projects
  • Gains consensus from various parties involved

This position manages all activities associated with the CAPA/CAB process, including the responsibility for accuracy and integrity of the associated systems.  The responsibilities of the CAPA Manager directly affect the ability of the organization to comply with global medical device regulations.  Some of the essential functions of this role include:

  • Contribute in development of procedures and practices to optimize and maintain a robust CAPA/CAB system as well as provide optimum customer service to all facilities and stakeholders
  • Management of the CAPA system, including  coordination and oversight of the Corrective Action Board (CAB) to ensure system adequacy, including analysis of data and trends, remedial actions, CAPA processing, tracking, closure and follow-up
  • Development and review of monthly, quarterly and annual CAPA metrics and summaries for distribution to key senior management
  • Participate in preparation and defense of process for corporate, FDA, and other international regulatory agency audits
  • Provide training, guidance and direction to sites for the CAPA process and system
  • Liase with IT department to maintain the CAPA process and tools and to participate in improvement efforts
  • Coach staff to leverage their strengths and develop their functional and managerial skills and attract, select and retain the best people to achieve business goals
  • Manage expenses to remain within current budget and assist with development of upcoming budgets

An ideal candidate would have experience with Pilgrim Smartsolve software.  Additionally, experience with class 1-3 medical devices and combination products and a solid working knowledge of FDA, ISO and international medical device regulations is highly desired.