Cardinal Health Principal Specialist, Quality Systems (Med Device) in Mansfield, Massachusetts

Principal Specialist, Quality Systems (Med Device)

Job Description:

Assists the Quality Systems Manager to maintain the integrity of the CAH Medical Segment QMS and to provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance to established regulations, standards and agency guidelines.

  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Supports maintenance of quality system requirements, including: internal audits, external audits, communication with Notified Body and regulatory agencies, quality metrics reporting, management review preparation, and training.
  • Manage and participate in the internal audit program by leading internal audits, internal audit scheduling, and training to ensure regulatory compliance.
  • Apply and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits as a member of the CAH Medical Segment quality management team.
  • Prepare metrics in support of trending and management review
  • Assist with QMS leadership for major initiatives such as EU MDR and MDSAP
  • Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.
  • Travel Required: minimal to moderate

Responsible for or more of the following:

  • As an individual contributor, carries out complex or novel assignments requiring the development of new or improved techniques or procedures
  • Work is expected to result in the development of new or improved techniques or procedures.
  • Work is expected to result in the development of new or refined materials, processes, and/or methods
  • As principal specialist, develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others
  • Applies quality engineering principles to lead investigations, and provide general support of the quality system..
  • Consults with supervisor concerning unusual problems and developments

Qualifications

  • Education and/or Experience: Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, with a minimum of 4 years of quality systems experience in an electro-mechanical medical device company. Current knowledge of FDA and international quality system requirements are a must. Direct experience managing an internal audit system or CAPA system strongly preferred.
  • 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

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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.

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.