Quality Engineer (质量工程师) - Shanghai

供应商质量对嘉德诺的贡献

质量管理制定并实施质量政策、程序和流程,以确保产品和服务符合监管标准和规范。

供应商质量负责在整个产品生命周期内管理外部供应商,包括评估和鉴定供应商、监控供应商绩效、根据适用法规和质量标准审核供应商的质量管理体系、提供指标以及解决质量和监管问题。

职位描述:

专注于供应商资格认证、供应商质量管理、CAPA和过程检查

职责:

  • 在新供应商的遴选、预评估、评估和资格认证中领导质量活动;

  • 专注于CAPA、风险缓解和风险评估

  • 与加工商/供应商紧密合作,通过有效的解决产品质量问题

  • 过程控制;与现有/潜在供应商合作,评估质量体系合规性和工艺能力,并对现有/潜在供应商进行现场审核,以验证和认证合规性和能力;

  • 参与关键到质量的项目,并为特殊质量项目提供支持;

  • 负责技术写作和SOP和WI的创建;

  • 跟进对审计观察结果的纠正/预防措施,并验证其有效性; 直接与营销、研发、采购、工程部门对接,为新供应商和新产品制定质量要求;

  • 领导供应商的质量绩效考核,支持经理组织和维护好供应商监督审核/年度审核总体计划

  • 支持提高QA对运营KPI管理的杠杆作用;

  • 交叉支持其他团队成员的工作。

任职要求:

  • 科学或工程学科的最低大学学位

  • 工程师 --至少2年以上医疗器械、制药或cGMP相关行业质量控制/质量保证经验 注册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 良好的沟通能力,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 熟悉国内和国际质量体系,特别是GMP/ISO13485/FDA QSR要求 ASQ CQE/证书六西格玛绿带优先

  • 良好的英语水平,尤其是在口头和书面交流上

Quality Engineer

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 / 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;

  • 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;

  • Participate in 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 support for the work of other team members.

Qualifications & Requirements:

  • Minimum College Degree in Science or Engineering discipline

  • QE--Minimum 2-years quality control/quality assurance experience in medical device, pharmaceutical or cGMP related industry

  • Certified ISO13485 internal auditor is a plus

  • 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.