Senior Quality Engineer (高级质量工程师) - Shanghai

职责总结:

专注于供应商资格,供应商质量管理,CAPA和过程检查

职责:

  • 领导新供应商选拔、预评价、评价和资格认证的质量活动;

  • 专注于 CAPA、风险缓解和风险评估

  • 与加工商/供应商密切合作,通过有效的过程控制解决产品质量问题;与现有/潜在供应商合作,评估质量体系合规性和过程能力,并现场审核现有/潜在供应商以验证和认证合规性和能力;

  • 领导/参与关键质量项目,为特殊质量项目提供支持;

  • 负责技术写作和SOP和WI的创建;

  • 跟进审计意见的纠正/预防措施并验证有效性;

  • 直接与营销,研发,采购,工程对接,以建立对新供应商和新产品的质量要求;

  • 领导供应商的质量绩效审查,支持经理组织和维护供应商监督审核/年度审核总体计划;

  • 支持提高运营KPI管理的QA杠杆;

  • 交叉支持其他团队成员的工作。

资格和要求:

  • 科学或工程学科的最低大学学位

  • 高级质量工程师--至少5年医疗器械,制药或cGMP相关行业的质量控制/质量保证经验

  • 认证ISO13485内部审计师

  • 足智多谋,有条理,能够在快节奏的环境中独立工作

  • 良好的沟通,人际交往能力

  • 具有技术素养,能够吸收多个产品系列的信息

  • 熟悉国内外质量体系,特别是GMP/ISO13485/FDA的QSR要求

  • ASQ CQE/证书六西格玛绿带是首选

  • 需要英语水平, 包括口语和书面交流

Summary:

Focus on supplier qualification, supplier quality management, CAPA and process check

Duties & Responsibilities:

  • Lead the quality activity in the selection, pre-evaluation, evaluation and qualification of new supplier;

  • Focus on CAPA, risk mitigation and risk assessment

  • Work closely with processors / suppliers to resolve product quality issue through effective process control; Work with the existing / potential supplier to evaluate the quality system compliance and the process capabilities, and on-site audit existing / potential supplier to verify & certify the compliance and the capabilities;

  • Lead / participate in critical to quality projects and provide supports to special quality projects;

  • In charge of technical writing and the creation of SOP and WI;

  • Follow up the corrective/preventative actions to the audit observation and verify the effectiveness;

  • Interface directly with Marketing, R&D, Sourcing, Engineering to establish the quality requirements to the new supplier and the new product;

  • Lead supplier’s quality performance review, support manager to well organize and maintain supplier surveillance audit/ annual audit master plan;

  • Support to improve QA leverage on operation KPI management; 

  • Cross supports for the work of other team members.

Qualifications & Requirements:

  • Minimum College Degree in Science or Engineering discipline

  • Senior QE--Minimum 5-year quality control/quality assurance experience in medical device, pharmaceutical or cGMP related industry

  • Certified ISO13485 internal auditor

  • Resourceful, organized and able to work independently in a fast-paced environment

  • Good communication, interpersonal skills

  • Technically literate, able to assimilate information on multiple product families

  • Knowledgeable of domestic and international quality systems, especially GMP/ISO13485/FDA QSR requirements

  • ASQ CQE/Certificate Six Sigma Green Belt is preferred

  • English proficiency required, especially in oral and written communication

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. 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.