Principal Supplier Quality Auditor (供应商质量审核员)

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.

Responsibilities

  • Conducts thorough Quality Management System, Process, and/or Product audits of all assigned Raw Material, Component, Services or Finished Goods Suppliers
  • Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques
  • Assists in analyzing regulatory requirements and overall program compliance to determine enterprise risk
  • Manages applicable internal corrective actions in response to audit findings to ensure effectiveness and avoid repeat issues
  • Identifies and proposes 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.
  • Leads the escalation process for unacceptable audits to appropriate management representatives

Accountabilities

  • Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, MDSAP (Medical Device Single Audit Program) and Risk Management (ISO 14971) to instill a culture dedicated to regulatory compliance
  • Knowledge of business platforms and processes such as Veeva Vault, SAP, BPCS and Agile PLM
  • Ability to multi-task and work in a high paced environment with an awareness of continued impact on compliance and operational performance
  • Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans
  • Excellent written and verbal communication skills to drive clear alignment of company and department goals
  • The ability to take responsibility for the professional development of you and your colleagues
  • Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations

Qualifications

  • Bachelors in related field preferred, or equivalent work experience, preferred
  • 4+ years of experience in related field, preferred
  • Experience performing Quality System audits in the Medical Device or other regulated industry.
  • Current knowledge of GMP auditing & regulation (FDA 21 CFR 820 & 21 CFR 210/211, & ISO13485) & international quality system requirements
  • Language Skills: Ability to read, analyze and interpret quality system documents, records, and technical procedures. 
  • Ability to write reports, business correspondence and procedure manuals.
  •  Ability to effectively present information to groups of managers, clients, and the general public.
  • Certificates, Licenses, Registrations: Certified Quality Auditor (CQA) to ASQ CBA, ASQ CQA, or ISO Lead Auditor training by an accredited organization and/or Certified Quality Engineer (CQE) strongly preferred.
  • Up to 50%-70% of travel required.

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

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.