Quality Assurance Specialist
1 month ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Cardinal Health in China-Shanghai Sourcing Office. This role is responsible for supplier qualification, supplier quality management, CAPA and process control.
About UsCardinal Health is a global integrated healthcare services and products company headquartered in Dublin, Ohio. With nearly 100 years of experience, we provide customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide.
Responsibilities- Participate in the selection, pre-evaluation, evaluation, and qualification of new suppliers.
- Foster collaboration with processors/suppliers to resolve product quality issues through effective process control.
- Work closely with existing/potential suppliers to evaluate quality system compliance and process capabilities.
- Conduct on-site audits to verify and certify compliance and capabilities.
- Participate in critical-to-quality projects and provide support for special quality projects.
- Create SOPs and WI documents.
- Follow up on corrective/preventative actions to audit observations and verify effectiveness.
- Interface directly with Marketing, R&D, Sourcing, Engineering to establish quality requirements for new suppliers and products.
- Support manager in organizing and maintaining supplier surveillance audit/annual audit master plan.
- Cross-support other team members as needed.
- Minimum College Degree in Science or Engineering discipline.
- Minimum 2-year quality control/quality assurance experience in medical device, pharmaceutical, or cGMP-related industry.
- Certified ISO13485 internal auditor.
- Resourceful, organized, and able to work independently in a fast-paced environment.
- Good communication and interpersonal skills.
- Technically literate, able to assimilate information on multiple product families.
- Knowledgeable of domestic and international quality systems, especially GMP/ISO13485/FDA QSR requirements.
- ASQ CQE/Certificate Six Sigma Green Belt preferred.
- English proficiency required, especially in oral and written communication.
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on experience, and a comprehensive benefits package including medical, dental, and vision coverage, 401(k) matching, and paid time off.
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