Vendor Quality Management Engineer

2 weeks ago

Shanghai, Shanghai, China Cardinal Health Full time

Contribution of Supplier Quality to Cardinal Health

Quality management involves the formulation and execution of quality policies, procedures, and processes to ensure that products and services meet regulatory standards and specifications.

Supplier quality is responsible for managing external suppliers throughout the product lifecycle, including the assessment and qualification of suppliers, monitoring supplier performance, auditing suppliers' quality management systems according to applicable regulations and quality standards, providing metrics, and resolving quality and regulatory issues.

Position Overview:

Focus on supplier qualification, supplier quality oversight, CAPA, and process evaluations.

Key Responsibilities:

Lead quality initiatives in the selection, pre-assessment, evaluation, and qualification of new suppliers; Emphasize CAPA, risk management, and risk evaluations; Collaborate closely with manufacturers/suppliers to effectively address product quality challenges; Process oversight; partner with existing/potential suppliers to assess compliance with quality systems and process capabilities, and conduct on-site audits of existing/potential suppliers to verify and certify compliance and capabilities; Engage in critical quality projects and provide support for specialized quality initiatives; Responsible for technical documentation and the development of Standard Operating Procedures (SOP) and Work Instructions (WI); Monitor corrective/preventive actions related to audit findings and verify their effectiveness; Interface directly with Marketing, R&D, Sourcing, and Engineering to establish quality requirements for new suppliers and products; Participate in the evaluation of supplier quality performance, assisting management in organizing and maintaining the supplier surveillance audit/annual audit master plan; Support enhancements to QA leverage on operational KPI management; Provide cross-functional support to other team members.

Qualifications & Requirements:

Minimum of a Bachelor's Degree in a Science or Engineering discipline; At least 2 years of quality control/quality assurance experience in the medical device, pharmaceutical, or cGMP-related industries; Certification as an ISO13485 internal auditor is advantageous; Resourceful, organized, and capable of working independently in a dynamic environment; Strong communication and interpersonal skills; Technically adept, able to assimilate information across multiple product lines; Familiarity with domestic and international quality systems, particularly GMP/ISO13485/FDA QSR requirements; ASQ CQE/Certificate Six Sigma Green Belt is preferred; Proficiency in English, especially in verbal and written communication.

Cardinal Health encourages applications from individuals who are returning to the workforce, people with disabilities, those without a college degree, and veterans.

Cardinal Health is committed to fostering an inclusive workplace that values diverse perspectives, experiences, and backgrounds. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves every 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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