Principal Supplier Quality Auditor

What Quality & Regulatory Audit contributes to Cardinal Health

Quality & Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements.

  • Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques.
  • Analyzes regulatory requirements and overall program compliance to determine enterprise risk.
  • Proposes and/or implements audit program enhancements.
  • Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation.
  • Communicates best practices observed to other business units.
  • Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action.

Accountabilities in this role:

  • Performs audits of suppliers for compliance to applicable government regulations, material specifications, international standards and company policies and procedures.
  • Initiates, plans, executes, reports, performs follow-up and closes supplier audits varying in scope (on-site or desktop assessments for on-boarding, surveillance, or special audits).
  • Serves as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors.
  • Selects appropriate team members for conducting supplier audits, as needed.
  • Assigns specific audit responsibilities to members of the audit team.
  • Represents the audit team in communication with internal management and the supplier.
  • Creates working documents as needed to accomplish supplier audit objectives.
  • Performs supplier re audits of deficient matters and corrective actions, as needed and required.
  • Prevents and resolves conflicts during the audit process.
  • Assigns classifications and documents supplier audit results in written audit reports that are distributed and reviewed by appropriate management.
  • Evaluates adequacy of supplier corrective action plans and works with supplier to ensure acceptable responses are provided.
  • Monitors supplier progress on corrective action responses to ensure timely completion, may escalate to management as needed.
  • Verifies implementation and effectiveness of corrective action taken by supplier.
  • Maintains supplier audit records as defined.
  • Generates data for management reviews, as needed.
  • Assists in formulating and implementing improvement to company policies and procedures.
  • Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
  • Responsible for following all company policies and procedures applicable to job function

    Qualifications required:

    • Bachelors in related field of study, or equivalent work experience,
    • 4+ years experience in related field, preferred
    • 2+ years working in the medical device industry in a supplier auditing role
    • ASQ CQA (Certified Quality Auditor)/ISO Lead Auditor or related certification, strongly preferred
    • Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles/tools and their applications
    • Proficiency in English and Spanish
    • Applied knowledge of Good Practice quality guidelines and regulations (GxP such as GMP, GLP, GCP, and GAMP)
    • Demonstrated critical thinking and problem solving skills
    • Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal document
    • Demonstrated project management skills
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

    What is expected of you and others at this level

    • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
    • May contribute to the development of policies and procedures
    • Works on complex projects of large scope
    • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
    • Completes work independently receives general guidance on new projects
    • Work reviewed for purpose of meeting objectives
    • May act as a mentor to less experienced colleagues
    • Ability to work under pressure and manage multiple tasks in a moderate to fast paced, deadline-driven environment
    • Demonstrated experience in quality auditing/engineering and corrective/preventative action
    • Good interpersonal skills and proven track record of demonstrating collaboration across the organization and at all levels
    • Ability to effectively prioritize and accomplish work with minimal supervision
    • Ability to use PC’s and associated Microsoft software and related applications