Medical Device Quality Engineer

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.

We are a leading provider of medical products and supply chain services across the healthcare continuum, from hospitals to laboratories, physician offices, and patients in the home.

Job Summary

We are seeking a Quality Assurance Specialist to join our team in Shanghai. The successful candidate will be responsible for supplier qualification, quality management, and process control.

Key Responsibilities

  • Participate 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 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.

What We Offer

We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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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