Supplier Quality Assurance Specialist
2 days ago
Location: Shanghai Sourcing Office, Kerry Everbright City
Reports to: Senior Quality Manager (based in Shanghai)
The Company:
Cardinal Health is a global healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, and more.
We connect patients, providers, payers, pharmacists, and manufacturers for integrated care coordination and better patient management.
With nearly 100 years of experience and approximately 50,000 employees in 46 countries, Cardinal Health ranks among the top 25 on the Fortune 500.
Job Summary:
Focusing on supplier qualification, quality management, CAPA, and process control to ensure the quality of medical products.
Duties & Responsibilities:
- Participate in supplier selection, pre-evaluation, evaluation, and qualification.
- Lead CAPA, risk mitigation, and risk assessment efforts.
- Closely collaborate with suppliers to resolve product quality issues through effective process control.
- Evaluate supplier quality system compliance and process capabilities.
- Participate in critical-to-quality projects and provide support for special quality projects.
- Develop SOPs and WI.
- Follow up on corrective and preventative actions.
- Interface with Marketing, R&D, Sourcing, and Engineering to establish quality requirements.
- Participate in supplier quality performance reviews and support quality surveillance audits.
- Support the improvement of QA leverage on operation KPI management.
Qualifications & Requirements:
- Minimum College Degree in Science or Engineering discipline.
- Minimum 2-year quality control/quality assurance experience in medical devices, pharmaceuticals, or cGMP-related industries.
- Certified ISO 13485 internal auditor.
- Resourceful, organized, and able to work independently.
- Good communication and interpersonal skills.
- Technically literate.
- Knowledgeable of domestic and international quality systems, especially GMP/ISO 13485/FDA QSR requirements.
- ASQ CQE/Certificate Six Sigma Green Belt is preferred.
- English proficiency required.
Candidates from diverse backgrounds are encouraged to apply. Cardinal Health supports an inclusive workplace and is an Equal Opportunity/Affirmative Action employer.
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