[C-884] - Senior Specialist, Supplier Quality Assurance

[C-884] - Senior Specialist, Supplier Quality Assurance

Senior Specialist, Supplier Quality Assurance
What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
The Senior Specialist, Supplier Quality Assurance position is responsible for participating in the management of medical device products, processes, and suppliers. This role will participate in, maintain, and sometimes lead quality and compliance activities for the Cardinal Health, Presource convenience kitting business. This role will help to ensure that component/product quality goals are met for components utilized with the Presource kitting business.




Responsibilities Support Presource Supplier Quality in the following ways:Work directly with component suppliers to resolve various quality concerns.Perform quality data analysis reviewing for trends and quality signals.Issue notifications to suppliers for newly identified component quality issues.Work with suppliers to follow-up and document their issue investigations.Provide status updates to management at Supplier Review Board and other quality assurance review meetings.Work cross-functionally with sourcing and plant manufacturing teams to ensure proper documentation and disposition is achieved for internally identified component quality issues.Ensure fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.Execute internal programs to define Quality guidelines and track adherence to these guidelines. Provide guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.Respond to significant quality issues and in support of the Manager,



conduct root cause analyses, report on relevant quality metrics and trends, and develop insights for internal stakeholders. Collaborate with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.Support the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.Update standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager. Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.Prepare responses to regulatory queries, regulatory audits, and corporate audits and gather necessary information from products and operations stakeholders.Support the Manager,



Quality Assurance in quality audits and inspections. Record quality issues and provide draft reports and insights to the Manager, for delivery to the Operations stakeholders.Provide guidance to junior level Specialists on complex issues, assist with onboarding trainings, and may review the work of Specialists prior to delivery to a Manager.Qualifications 2-4 years of experience in supplier quality or similar fieldBachelor's degree in related field, or equivalent work experienceMust have Advanced English and SpanishMust have analytical skills in Excel (Pivot tables, graphing)Must have experience in compiling and presenting data (PowerPoint)Must be bilingual (English,



Spanish)Previous experience in Veeva Vault (preferred)Knowledge of medical device or ISO13485 (preferred)What is expected of you and others at this level Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes action to resolveApplies judgment within defined parametersReceives general guidance and may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyCandidates 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.

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