Senior Specialist, Supplier Quality Assurance G-606

Senior Specialist, Supplier Quality Assurance G-606

.Senior Specialist, Supplier Quality AssuranceWhat Quality Assurance contributes to Cardinal HealthQuality 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.ResponsibilitiesSupport 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

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