What Quality Systems 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.
Assists the Quality Systems Manager to maintain the integrity of the CAH Medical Segment QMS.
Supports maintenance of quality system requirements, including internal audits, quality metrics reporting, management review preparation, and training.
Participate in the internal audit program by leading internal audits.
Participate in external regulatory audits.
Prepare metrics in support of trending and management review and supports the preparation of management review slides.
Interface within the Audit database tool. Is an SME for the Audit program and interface with finding owners to ensure on time and compliant audit investigations.
Assists the with Quality Systems Manager with compliance initiatives such EU MDR.
Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.
Travel Required: Moderate
Bachelors in related field, or equivalent work experience, preferred
4+ years experience in related field, preferred
Current knowledge of FDA, ISO 13485 and international quality system requirements are a must.
Ability to read, analyze and interpret general business periodicals, professional journals and technical procedures.
Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Certificates, Licenses, Registrations: Certification by ASQ as certified quality auditor (CQA) and/or quality engineer (CQE) preferred
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
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.