Senior Specialist, Quality
6 개월전에
The Company and Business
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide.
The company provides clinically proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with approximately 50,000 employees in 46 countries, Cardinal Health ranks among the top 25 on the Fortune 500.
Reports to: QRA Manager based in Korea
QA Responsibilities
Develop and maintain Quality Management System in compliance with MFDS regulatory and internal requirements and support to separate the QMS document aligning with corporate separation strategy.
Responsible for product complaints, including receiving and reporting complaints to appropriate manufacturing sites, following up on complaint investigation and returns, and adverse event reporting to MFDS.
Prepare Quality Records, including product inspection, import and release, including returned products, as needed.
Implement Quality holds as needed and work with manufacturing site QA and RA teams for field actions and recalls
Closely work with manufacturing site to maintain and renew KGMP certificates with updated information
Audit/monitor internal quality compliance level, as well as daily quality performance
Train distributors and dealers regarding complaint process to meet local requirement
Manage the supply history record provided by 3PL/related parties and timely report to the authority in accordance of UDI regulation
RA Responsibilities
In coordination with QRA Manager, develop the effective strategy to separate the product license, KGMP and related regulatory binder aligning with corporate strategy.
Directly involve in application, prepare submission, and review response for the separation of product license, KGMP and related regulatory binder.
Build and maintain close relationships/communication with MFDS, government agencies and relevant stakeholders to ensure smooth and timely completion of regulatory application
Monitor regulations and provide regulatory intelligence especially related with the corporate separation.
Ensure review of product labeling and e-ifu for accuracy and compliance with regulations aligning with corporate separation timeline.
Do every work in compliance with regulatory requirements and Cardinal Health corporate requirement
Requirements/Qualifications:
Bachelor’s degree or higher degree in related field
KGMP/ISO13485/ISO9001 experience is highly preferred
Minimum 3 years RA/QA experiences in medical devices industry
In-depth knowledge of MFDS regulations, ISO13485 and GMP
Strong verbal and written communication in English and Korean
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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