Supplier Quality Manager

6 days ago

Jingan Qu, China Cardinal Health Full time

About Cardinal Health

Cardinal Health is a global healthcare services and products company that provides customized solutions for hospitals, health systems, pharmacies, and other healthcare providers.

Our Business

We are a leading provider of medical products and supply chain services across the healthcare continuum, from hospitals to 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.

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.
  • 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 their 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 ISO13485 internal auditor.
  • Resourceful, organized, and able to work independently in a fast-paced environment.
  • Good communication and interpersonal skills.
  • Technically literate and 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 is preferred.
  • English proficiency required, especially in oral and written communication.

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