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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 Assuranc e 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

• This position will 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.

• Works with suppliers to follow-up and document their issue investigations.

• Provides 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.

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.

• Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.

• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders. Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.

• Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.

• Updates 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.

• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.

• Supports the Manager, Quality Assurance in quality audits and inspections. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.

• Provides guidance to junior level Specialists on complex issues, assists 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 field

• Bachelor's degree in related field, or equivalent work experience

• Must have Advance English and Spanish

• Must have analytical skills in Excel (Pivot tables, graphing)

• Must have experience in compiling and presenting data (power point)

• 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 tasks

• Works on projects of moderate scope and complexity

• Identifies possible solutions to a variety of technical problems and takes action to resolve

• Applies judgment within defined parameters

• Receives general guidance and may receive more detailed instruction on new projects

• Work reviewed for sound reasoning and accuracy

Candidates 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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