【质量体系主管-ISO13485招聘】_2024广州质量体系主管-ISO13485招聘信息-猎聘

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职位介绍: Job summary for QMS Quality System Supervisor 1.Overall lead and coordinate all related activities with each functional department and /or each Workcell relate to the QMS. 2.To co-ordinate plant wide quality and systems improvement programs. Requirement 1.College / Diploma / Certificate, in EMS industry field with minimum 8 years quality control and quality management system experience preferable, minimum 3 years’ experience of team leader, science and engineering related major is preferred. 2.Proficiency and knowledgeable in the QMS: ISO 13485 and FDA is basic, if candidate also is proficiency and knowledgeable in IATF 16949, VDA 6.3, etc., it will be priority. 3.Able to communicate clearly and effectively in both verbal and written media. 4.Good at problem-solving skill (e.g., PDCA，8D CAR, Lean Six Sigma tools). 5.Skillful at excel data analysis, other data analysis tools (e.g. SQL, PowerBI, Python, DataEase, etc.) are preferred. 6.Fluent in oral and written English Job description for QMS Quality System Supervisor 1.QMS Internal Audit 1.1 Conduct risk assessment for workcell & QMS Process and convert into QMS annual internal audit plan, e.g. ISO 13485, ISO 9001, IATF 16949 QMS internal audits. 1.2 Review QMS annual internal audit plan in JCAS system. 1.3 Lead team to conduct specific ISO 13485 QMS semi-yearly/ annual internal audit. 1.4 Supervise team to follow up QMS internal audit lesson learnt and work out systematic improvement action plan. 1.5 Conduct special audit, such as Change Management, PPAP, CSR audit etc. 1.6 Conduct weekly/ semi-yearly plant level JOS(Jabil Operations System) audit. 2.QMS External Audit 2.1 Lead team to prepare and coordinate ISO 13485 and FDA external audit. 2.2 Take part in the other QMS external audit, such as ISO 9001, IATF 16949, etc. 2.3 Lead team to follow up ISO 13485 and FDA external audit findings, and take part in other QMS standards external audit findings improvement activities. 3. Customer Audit 3.1 Support new/existing customer audit. 3.2 Assist workcell to get preparation for typical customer audit. 4.Management Review 4.1 Lead team to conduct ISO 13485 Management Review. 5.QMS Document Review 5.1 Conduct global QMS document gap analysis review and train if needed, especially for medical sector related documents. 5.2 Follow up global document gap analysis status. 5.3 General document collaboration review 5.4 Simplify, Optimize and Standardize the process and revise QMS related document. 6.Training & Development 6.1 Conduct training about ISO 13485 and FDA standard, or other QMS standard, e.g., ISO 9001, IATF 16949, VDA 6.3 etc. for newcomer or per business required. 6.2 Provide support to other departments on systems related questions and problems. 7.Digital Solution 7.1 Work out digital solution for function or workcell processes and tasks to improve the process efficiency and quality. 8. Advanced quality involvement for new workcell. 8.1 Arrange training about ISO 13485, FDA, ISO 9001, IATF 16949 etc. QMS related procedures and customer requirement for team members from new workcell. 8.2 Conduct CSR gap analysis and follow up actions for gap during audit. 8.3 Conduct specific audit to new workcells based on risk assessment. 9.CSR (Customer specific requirement) 9.1 Training CSR for workcell members. 9.2 Support to establish CSR checklist for wokcell. 9.3 Conduct internal CSR audit for workcell. 10.Follow QA SME Manager’s other job assignment. QMS质量体系主管工作总结 1.全面领导和协调各职能部门的所有相关活动和/或每个工作单元与QMS相关。 2.协调整个工厂的质量和系统改进计划。要求 1.大专/文凭/证书，EMS行业领域，至少8年有质量控制和质量管理体系工作经验者优先，3年以上团队领导工作经验，理工科相关专业优先。 2.熟练掌握QMS：ISO 13485和FDA是基础，如果候选人熟练掌握IATF16949、VDA6.3等相关知识，优先考虑。 3.能够在口头和书面媒体上进行清晰有效的沟通。 4.善于解决问题（如PDCA、8D CAR、精益六西格玛工具）。 5.擅长excel数据分析，其他数据分析工具（如SQL、PowerBI、Python、DataEase等）。 6.英语口语和书面流利 QMS质量体系主管职位描述 1.QMS内部审核 1.1对工作单元和QMS过程进行风险评估，并转化为QMS 年度内部审计计划，例如ISO 13485、ISO 9001、IATF 16949 QMS内部审计。 1.2审核JCAS体系中的QMS年度内部审核计划。 1.3带领团队进行具体的ISO 13485 QMS半年/年度内部审计。 1.4监督团队跟进QMS内部审核的经验教训并制定系统的改进行动计划。 1.5进行专项审核，如变更管理、PPAP、CSR审核等。 1.6每周/每半年进行一次工厂级JOS（捷普运营系统）审计。 2.QMS外部审计 2.1领导团队准备和协调ISO 13485和FDA外部审计。 2.2参与其他QMS外部审核，如ISO 9001、IATF 16949等。 2.3领导团队跟进ISO 13485和美国食品药品监督管理局的外部审计结果，并参与其他QMS标准外部审计结果改进活动。 3.客户审计 3.1支持新/现有客户审计。 3.2协助工作小组为典型客户审计做好准备。 4.管理评审 4.1领导团队进行ISO 13485管理评审。 5.QMS文件审查 5.1进行全球QMS文件差距分析审查，并在需要时进行培训，尤其是医疗部门相关文件。 5.2跟踪全球文件差距分析状况。 5.3一般文件协作审查 5.4简化、优化和标准化过程，修订QMS相关文件。 6.培训与发展 6.1进行有关ISO 13485和FDA标准或其他QMS标准的培训，例如。， ISO 9001、IATF 16949、VDA 6.3等。 6.2就系统相关问题向其他部门提供支持和问题。 7.数字化解决方案 7.1为功能或工作单元流程和任务制定数字解决方案，以改进工艺效率和质量。 8.新工作单元的高级质量参与。 8.1安排ISO 13485、FDA、ISO 9001、IATF 16949等QMS相关培训程序和客户对新工作单元团队成员的要求。 8.2进行CSR差距分析，并在审计期间跟进差距。 8.3根据风险评估对新的工作单元进行具体审计。 9.CSR（客户特定要求） 9.1培训工作小组成员的CSR。 9.2支持为wokcell建立CSR检查表。 9.3对工作单元进行内部CSR审核。 10.遵循QA SME经理的其他工作任务。

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