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Quality Assurance Specialist

2 months ago


Jingan Qu, China Cardinal Health Full time

About Cardinal Health

Cardinal Health is a leading global healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide.

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.

Our Medical Segment

Our Medical Segment is a global $15B provider of medical products and supply chain services across the healthcare continuum from hospitals to laboratories, physician offices, surgery centers, and patients in the home.

Job Summary

We are seeking a Quality Assurance Specialist to focus on supplier qualification, supplier quality management, CAPA, and process control. The successful candidate will participate in the quality activity in the selection, pre-evaluation, evaluation, and qualification of new suppliers.

Key Responsibilities

  • Participate in the quality activity in the selection, pre-evaluation, evaluation, and qualification of new suppliers;
  • Focus on CAPA, risk mitigation, and risk assessment;
  • Work closely with processors/suppliers to resolve product quality issues through effective process control;
  • Work with existing/potential suppliers to evaluate the quality system compliance and process capabilities, and conduct on-site audits to verify and certify compliance and capabilities;
  • Participate in critical-to-quality projects and provide support to special quality projects;
  • In charge of technical writing and the creation of SOPs and WIs;
  • Follow up on corrective/preventative actions to audit observations and verify effectiveness;
  • Interface directly with Marketing, R&D, Sourcing, and Engineering to establish quality requirements for new suppliers and products;
  • Participate in supplier quality performance reviews and support managers in organizing and maintaining supplier surveillance audits/annual audit master plans;
  • Support the improvement of QA leverage on operation KPI management;
  • Cross-support for the work of other team members.

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 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/ISO 13485/FDA QSR requirements;
  • ASQ CQE/Certificate Six Sigma Green Belt is preferred;
  • English proficiency required, especially in oral and written communication.

Cardinal Health is an Equal Opportunity/Affirmative Action Employer

We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. We are committed to diversity, equity, and inclusion in all aspects of our business.