Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Cardinal Health.
About the RoleThis is an excellent opportunity for a quality professional to work in a dynamic environment and contribute to the success of our organization.
Job Description- Lead quality activities in supplier selection, evaluation, and qualification;
- Develop and implement CAPA, risk mitigation, and risk assessment strategies;
- Collaborate with processors and suppliers to resolve product quality issues through effective process control;
- Participate in critical-to-quality projects and provide support for special quality initiatives;
- Conduct on-site audits to verify compliance and capabilities of existing/potential suppliers;
- Interface directly with Marketing, R&D, Sourcing, and Engineering to establish quality requirements for new suppliers and products;
- Support manager in organizing and maintaining supplier surveillance audit/annual audit master plan;
- Improve QA's leverage on operation KPI management;
- Minimum 2 years' experience in quality control/quality assurance in medical device, pharmaceutical, or cGMP-related industries;
- Certified ISO13485 internal auditor is a plus;
- Resourceful, organized, and able to work independently in a fast-paced environment;
- Good communication, interpersonal skills, and technical literacy;
- Knowledgeable of domestic and international quality systems, especially GMP/ISO13485/FDA QSR requirements;
- ASQ CQE/Certificate Six Sigma Green Belt is preferred;
- English proficiency required, especially in oral and written communication.
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience.
A comprehensive benefits package, including health insurance, retirement plans, and paid time off.
The opportunity to work in a dynamic environment and contribute to the success of our organization.
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