Principle Spec. Quality System Management

Cardinal Health Santa Clara , CA 95051

Posted 3 weeks ago

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

Qualifications

  • 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.

  • Language Skills:
    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.


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Principle Spec. Quality System Management

Cardinal Health