Senior Quality Engineer

2 weeks ago

Shanghai, Shanghai, China Cardinal Health Full time
Job Summary:Focus on supplier qualification, supplier quality management, Corrective and Preventive Action (CAPA), and process inspection.Duties & Responsibilities:
  • Lead quality activities in selecting, pre-evaluating, evaluating, and qualifying new suppliers;
  • Focus on CAPA, risk mitigation, and risk assessment;
  • Collaborate closely with processors/suppliers to address product quality issues through efficient process control;
  • Evaluate the compliance of quality systems and process capabilities of existing/potential suppliers, and conduct on-site audits to verify and certify compliance and capabilities;
  • Lead/participate in key quality projects and support special projects;
  • Responsible for technical writing and creating Standard Operating Procedures (SOP) and Work Instructions (WI);
  • Monitor the implementation and effectiveness of corrective/preventive actions based on audit findings;
  • Interface with Marketing, Research & Development, Procurement, and Engineering to establish quality requirements for new suppliers and products;
  • Lead supplier quality performance reviews and assist in organizing and maintaining supplier audit plans;
  • Support the enhancement of Quality Assurance effectiveness in operational KPI management;
  • Provide cross-functional support to other team members.
Qualifications & Requirements:
  • Bachelor's degree in Science or Engineering;
  • Senior Quality Engineer with at least 5 years of experience in quality control/assurance in medical devices, pharmaceuticals, or related industries;
  • Certified ISO13485 internal auditor;
  • Resourceful, organized, and capable of independent work in a fast-paced environment;
  • Excellent communication and interpersonal skills;
  • Technically skilled with the ability to absorb information from multiple product lines;
  • Familiarity with domestic and international quality systems, particularly GMP/ISO13485/FDA QSR requirements;
  • Preferred certification in ASQ Certified Quality Engineer (CQE) or Six Sigma Green Belt;
  • Proficiency in English, both oral and written.
Candidates from various backgrounds, including those returning to work, individuals with disabilities, non-college graduates, and Veterans, are encouraged to apply. Cardinal Health is committed to fostering an inclusive work environment that values diverse perspectives and backgrounds. We believe that embracing our differences leads to innovative solutions that benefit our customers. Cardinal Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, gender, sexual orientation, pregnancy, veteran status, marital status, creed, public assistance status, genetic information, or any other status protected by law.

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