**_What Quality Control contributes to Cardinal Health_**
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.
**_Job Summary_**
Coordinate the execution of the CAB/Management Review process, generate information and proposed actions as input for that process by analyzing relevant Quality System data and assure all required evidence is generated from this process. Follow up the CAPA and Audit processes; support the stakeholders in achieving the objectives of that process by providing timely information and guidance and in achieving the different investigative requirements when applicable.
Receive and review the evidence of the implementation actions in CAPA and Audit system; support the investigative process for CAPA, Internal Audit responses and NCR, when applicable. Lead the Quality Indicators for the site. Support the quality system audits management as required. Identify, evaluate, and execute opportunities for continuous improvement consistently. Maintain company documentation of procedures and ensure compliance with established certified standards, applicable regulations, and company policies.
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Responsibilities_**
- Assure compliance with regulations as ISO13485, JPAL, QSRs, ANVISA and others as applicable though CAB/MRB/ Management Review reports/metrics preparation and review, submit these reports periodically and in as needed basis. Perform tracking and follow up of pending exception reports and actions to ensure timely closure. Collect, track, trend and analyze quality metrics for CAB/ Management Reviews. For Management Review/CAB meetings, takes, distributes minutes, and follows up on open items until completion.
- Assist the revision of CAPA investigations and Internal Audit responses when required. Support execution of QA plans actions related to QA systems management and QA control activities as required. Support NCs events evaluation when QA systems are involved.
- Receive and review applicable CAPA and Internal Audits' responses and actions implementation evidence. Participates in the internal audit process and as a member of the external audit management team. Perform the trainings required for the access of Smartsolve access system for CAPAs, Audits and NCs. Perform tracking and follow up for CAPA, Internal Audits and QA plans actions to ensure timely closure.
- Perform data analysis for KPIs and other quality objectives/projects as required.
- Execute change control process for applicable procedures under QA systems managements as required.
- Performs other related duties as required.
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Qualifications_**
- 1-2 years of experience
- Secondary Studies Completed. University studies initiated
- Must be able to speak, read and write in the English language. Bilingual preferred.
- Requires excellent computer skills, proficiency in MS Office suite and Minitab preferred.
**_ What is expected of you and others at this level_**
- Applies acquired knowledge and skills to complete standard tasks
- Readily learns and applies new information and methods to work in assigned area
- Maintains appropriate licenses, training and certifications
- Works on routine assignments that require some problem resolution
- Works within clearly defined standard operating procedures and/or scientific methods
- Adheres to all quality guidelines
- Works under moderate degree of supervision
- Work typically involves regular review of output by work lead or supervisor
- Refers complex unusual problems to supervisor
- 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._