Supplier Quality Assurance Specialist

2 weeks ago

Jingan Qu, China Cardinal Health Full time

Job Summary:

We are seeking a highly skilled Supplier Quality Assurance Specialist to join our team at Cardinal Health. As a key member of our quality team, you will be responsible for ensuring the quality of our medical products and services.

Key Responsibilities:

  • Participate in the selection, evaluation, and qualification of new suppliers.
  • Focus on CAPA, risk mitigation, and risk assessment.
  • Work closely with processors and 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 and 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 and 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 a science or engineering discipline.
  • Minimum 2-year quality control/quality assurance experience in the medical device, pharmaceutical, or cGMP-related industry.
  • Certified ISO 13485 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/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. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.

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