Senior Quality Assurance Engineer

1 month ago

Shanghai, Shanghai, China Cardinal Health Full time

Job Summary:

This is an exciting opportunity to join Cardinal Health as a Senior Quality Engineer where you will play a critical role in ensuring the quality of our medical devices and pharmaceuticals. As a key member of our quality team, you will be responsible for leading supplier qualification activities, conducting internal audits, and implementing corrective actions.

About the Role:

  • You will lead the selection, pre-evaluation, evaluation, and qualification of new suppliers, ensuring they meet our quality standards.
  • You will focus on CAPA, risk mitigation, and risk assessment to identify and resolve potential quality issues.
  • You will work closely with processors and suppliers to implement effective process control and resolve product quality issues.
  • You will lead or participate in critical quality projects and provide support to special quality projects.
  • You will create and maintain SOPs and WI, and follow up on audit observations to ensure effective corrective actions.
  • You will interface directly with Marketing, R&D, Sourcing, and Engineering to establish quality requirements for new suppliers and products.
  • You will lead supplier quality performance reviews and support the development of a surveillance audit plan.
  • You will support the improvement of QA leverage on operation KPI management.

About You:

  • You have a minimum 5-year quality control/quality assurance experience in medical device, pharmaceutical, or cGMP-related industries.
  • You are a certified ISO13485 internal auditor.
  • You possess excellent communication and interpersonal skills.
  • You are resourceful, organized, and able to work independently in a fast-paced environment.
  • You are knowledgeable of domestic and international quality systems, especially GMP/ISO13485/FDA QSR requirements.
  • ASQ CQE/Certificate Six Sigma Green Belt is preferred.

What We Offer:

We offer a competitive salary range of $110,000 - $140,000 per annum, based on experience and qualifications. Our comprehensive benefits package includes health insurance, retirement savings, and paid time off.

About Cardinal Health:

Cardinal Health is an Equal Opportunity/Affirmative Action employer committed to diversity, equity, and inclusion. We welcome applications from diverse candidates who share our values and commitment to excellence.

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