Quality Manager (SZP2)

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 GENERAL FUNTION
基本职能

？ Manage the Quality Assurance department, develop and implement policies and procedures to assure product conformance to company specifications, government regulations and industry standards.
管理质量部门，为保证符合公司要求，法规和工业标准，负责开发和执行政策和程序。


JOB RESPONSIBILITIES
工作职责
Quality Assurance质量保证
？ Responsible for both Quality Assurance and Quality System functions.
负责质量保证和质量体系方面
？ Provides Quality Assurance review for all product lines residing in the plant to ensure conformance to product specifications, and that non-conformance products are appropriately reviewed and disposition.
负责质量评审，保证工厂所有生产的产品符合生产要求，并且不合格品能得到合适的评审和处理。
？ Develop plant’s quality standards and procedures, including in-process quality and out-going quality plans. Responsible for finish products release.
负责开发现工厂的质量标准和程序，包括过程质量和成品质量。负责成品放行。
？ Ensures an effective documentation system is in place and is maintained so as to meet our Quality Systems requirements.
为了满足质量体系的要求，保证有一个有效运行的文件体系，并对其进行维护。
？ Establishes a system for approving validation protocols, validation procedures and documented results.
建立验证方案，验证程序和保留验证记录的一个体系。
？ Assures that new manufacturing processes are capable of producing product in conformance with established specifications and takes the lead in the validation of all manufacturing processes within the plant.
负责确保新生产流程具有生产能力和主导所有生产流程验证。
？ Manages customer complaints and ensures corrective actions are implemented and communicated to customers as required. Works in conjunction with relevant departments, to align activities relating to customer complaint improvements.
管理顾客投诉并保证纠正措施的执行和顾客的沟通工作。与相关部门一起，完成相关顾客投诉的提高工作。

？ Takes the lead in ensuring the plant is capable of meeting the requirement of external audit(s).
确保工厂有满足外部审核要求的能力
？ Takes the lead in all quality related aspects pertaining to new or alternate material implementation.
主导所有与质量相关的新物料和替换物料的执行工作。
？ Work in conjunction with the Materials department to perform vendor audits with key suppliers and contributes to the overall plant vendor relations. Works jointly with vendor on cost reduction efforts.
与物料部门一起对主要供应商进行审核，并支持工厂所有与供应商相关的质量工作。与供应商共同运作，为降低成本努力。
？ Accountable for maintenance and calibration of equipment owned by Quality department.
负责设备的维护和校验
？ Performs periodic competitive analysis to monitor competitors’ product quality performance.
定期对竞争对手的产品进行质量分析。
？ Acts as a management representative who holds the authority and responsibility for:
作为管理者代表的职责：
a) Ensuring that product meets specified requirements; ensuring that the requirements of ISO 13485, Japan PMDL, and US FDA 21 CFR Part 820: Quality System Regulation and the company’s documented Quality System are implemented and maintained.
确保产品能满足技术要求，ISO13485，日本PMDL和美国FDA21 CFR Part820质量体系法规，并且记录质量体系的执行和维护。
b) Ensuring that regular internal Quality System audits are performed; and coordinating and monitoring the periodic management review of the Quality System.
确保定期的执行内部质量体系审核；并协调和监督管理评审。
c) Ensuring the performance of the Quality System is reported to management for review and as basis for improvement.
确保质量体系的运行情况是被报告出来的以便于评审的管理和作为改进的基础。
d) Ensures that specific requirements of other standards are met.
确保满足其他标准的特殊要求。
e) Responsible for and participates in the development activities of associates.
负责和参与员工的开发工作。
f) Maintains a safe and healthy work environment by complying with all related safety regulations and environmental policies in the Company.
依照安全相关的法规和环境政策，维护安全和健康的工作环境。

Regulatory Compliance法规
？ Manage the Internal Quality Audit Program to include:
管理内部质量审核程序包括：
a) Establishment and maintenance of guidelines for internal audits.
建立和维护内部审核的指导。
b) Preparation and maintenance of the Internal Quality Audit Plan.
准备和维护内部审核计划。
c) Monitoring and tracking of the internal quality audit performed as per the approved Internal Quality Audit Plan.

根据批准的内部审核计划，监督和跟踪内部审核的执行情况。
d) Managing the pool of appointed Internal Quality Auditors.
管理被指定的内审人员库。
e) Conducting Internal Quality Audit as being assigned and per documented procedure.
主导内部审核，并记录。
f) Presentation of regular status updates and trend analysis reports to the Management team.
定期向管理层汇报状态和数据分析结果。

？ Maintenance of the External Quality Audit Program, includes:
维护外部审核程序，包括：
a) Establish and maintain guideline for external audits.
建立和维护外部审核的指导。
b) Assist in the preparation of the plant for external quality audit by regulatory authorities, or any other third party.
协助工厂准备外部法规审核，或第三方审核。
c) Follow up of corrective actions committed for nonconformities cited during the audit to ensure actions are implemented according to plan.
跟踪纠正措施，并保证根据计划执行。
d) Perform follow-up audit to verify implemented corrective actions.
跟踪审核验证纠正措施的执行情况。
e) Provide regular status updates and trend analysis report to the Department Manager and the Steering Team.
定期向部门经理和指导小组汇报状态和数据分析结果。

？ Maintenance of all Internal and External Quality Audit Reports per established
procedure and in accordance to the Plant quality system that includes
compliance to ISO 13485, Japan PMDL, Canadian CMDCAS
and US FDA 21 CFR Part 820: Quality System Regulation and any other
applicable standards.
维护所有的内审和外审报告，并符合工厂需要遵从质量体系要求（包括ISO13485，
日本PMDL，加拿大CMDCAS，美国FDA21CFR Part820 质量体系法规和其它适用的标准）。

Others其他
？ Work in conjunction with Manufacturing, Product Support, Engineering, Quality
Assurance and Materials counterparts on validation activities, material change projects, cost improvement initiatives and new product introduction.
协同生产部，产品支持部，工程部，物料部一起完成验证，物料变更，成本控制和新产品导入。
？ Plan and submit timely operational budget and forecast. Review and monitor expenditure to ensure variance-to-budget (both capital and expenses) is minimized.
及时计划和递交经营预算。评审和监督支出费用使其减小化。


？ Participates as a member of the Steering team to set directions and expectation of the Resource/Process teams and also to avail as a resource to the Resource/Process teams.
作为指导小组成员去指导资源/制程小组，使其得到有效的信息。
？ Lead, coach and develop both the Resource and Process Support team members to strive for continuous improvement and maintain good team spirit.
领导、指导和开发资源和制程支持小组成员，使其更好的为持续改进和维护团队合作而工作。
？ Ensures open and complete communication with both internal and external customers.
对内审和外审的人员，确保能进行开放式的和完整的沟通。
？ Maintain good communication, professional relationship with the relevant outside parties such as officials, consultants, suppliers, etc, to accomplish best possible results in terms of timeliness, workmanship, safe practices, regulatory compliance, cost effectiveness and service standard, while ma


Education 教育
？ Degree in Science / Engineering (majoring in Bio-Chemistry, Pharmaceutical or Chemistry), with formal training in Quality Control techniques.
理工科学历（主修生物化学，药学或化学），有质量控制技术的培训。

Experience 经验
？ Minimum 5 years’ experience in medium-to-large size manufacturing plant for medical devices and/or pharmaceutical industries.
至少5年在大中型医疗器械公司或制药公司工作经验
？ Experience in regulatory affairs and strong working knowledge of ISO9000, ISO13485, FDA, PMDL, CE, CFDA.
有法规工作经验，熟悉ISO9000，ISO13485，FDA，PMDL，CE，CFDA
？ Registered or Lead Assessor will be preferred and Clinical experience will be a plus.
有注册，临床经验更加。

Skill / Knowledge / Abilities 技能/知识/能力
？ Bi-lingual (English and Mandarin), with excellent interpersonal and presentation skill, and knowledgeable in governmental registration activities.
双语（英语和中文），有优秀的人际关系和演讲技巧，熟悉官方注册要求。
？ Strong leadership, good business acumen and strong analytical skills.
擅长领导，良好的商业头脑和分析技巧。
？ High level of loyalty and integrity.
忠诚和诚信
？ Firm and able to take independent and professional stands on matters.
能独立和专业的处理事宜。

？ Work well under pressures with short deadlines, and able to handle multiple
抗压力好，能从事多重事宜。
？ Complex projects in an organized methodical manner with minimal direction.
复杂的项目能有条理有系统地处理。
？ Embrace diversity and the ability to work cohesively within a multinational team in an international environment in attaining common goal(s).
接受多元化，能跨部门工作并共同完成目标。
？ Ability to learn quickly and adjust personally and to manage change within assigned team to respond to changes in customer requirements.
学习能力强，能自我调整。
？ Good ethical behavior, ensuring that activities carried out within and outside the organization are executed in accordance with the Company’s Code of Ethics, with professionalism and in the best interest of the Company.
良好的职业道德，在公司内外能遵守公司的道德规范，并有专业精神，以公司利益为先。