QC及计量室高级主管

Job Summary
职位概述
Plans, coordinates, and supervises quality control to ensure continuous acceptance activities and documentation of products consistent with established standards, FDA and GMP regulations by performing the following duties personally or through subordinate Team Members (TM).
计划，协调，监督质量控制，确保产品和文件符合制定的标准，FDA和GMP要求。





Job/ Position Title:

Senior QC and Metrology Lab Supervisor


Supervisor (Position):

Senior QA/RC manager


(Management-) Level:

Supervisor





工作/职位名称

QC及计量室高级主管


主管 (职位):

QA/RC 高级经理


(管理-) 级别:

主管

Key Position Responsibilities
主要岗位职责
§ Actively develops and supports QC and metrology lab, ensures total participation and continuous improvements are realized and maintained.
发展并支持QC及计量室团队，确保实现并维持其持续改进。
§ Develops and implements quality surveillance programs to assure product meets specified requirements.
执行质量控制程序确保产品符合相关要求。
§ Directs TMs engaged in inspection activities to ensure continuous control over materials, products and appropriate segregation of materials.
指导团队成员参与检验活动，确保持续控制原材料和产品，必要时隔离原材料。
§ Plans, promotes and organizes documented training activities related to inspecting product quality and standards for QC and metrology lab TMs.
计划，促进和组织QC及计量室团队成员的质量检验和标准的培训活动。
§ Guaranty respect of GxP’s (mainly but not limited to manufacturing and documentation) and line clearance in the inspection areas.
担保检验区域的GXP（主要但不限于良好的制造习惯及良好的记录习惯）和在线清理要求。
§ Participates in Material Review Board (MRB) process for inspection area non-conformances.
参与检验区域的不合格品评审。
§ Directs calibration of measurement and test equipment to determine conformance to standards; maintains traceability and documentation of all required calibrations to recognized standards.
指导测量和试验设备的校准确保符合标准，保持追溯和记录所有需要校准的标准。
§ Develops short and long-term strategic plans for the acquisition of measurement systems to support changing business requirements.
发展短期和长期计划的测量系统，支持不断变化的业务需求。
§ Maintains appropriate stock of spare parts to facilitate timely repair of measurement and test equipment.
维持适当的备件库存，以便及时修复测量和试验设备。
§ Leads and supports implementation of continuous improvement activities (e.g. Measurement Systems Analysis (Gage R&R), ETQ Reliance Quality System Software, etc.).
领导并支持实施持续改进活动（如测量系统分析，质量系统软件ETQ等）。
§ Facilitates internal and external audits to ensure the effectiveness of the Quality Management System.
便利内部和外部审核确保质量管理体系的有效性。
§ Ensures company policies and procedures are applied equitably and consistently throughout the QC and metrology lab area
确保QC及计量室区域合理并始终执行公司政策和程序。
§ Provides input into budget development for dept. Ensures compliance with approved budget targets.
提供部门投入预算确保与批准的预算目标一致。
§ Exercises common sense and good judgment.
运用常识及良好的判断力。
§ Other duties may be assigned.
其他分配的任务。


Experience
经验
Skills and abilities (can do criteria)
技能和资质（使得目前可以去执行一些工作）
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
为了顺利完成此项工作，个人必须能够完成各项基本职责，下面列出的要求是代表性的知识，技能，和/或能力。合理的建议也许能使人履行基本职能。
§ Bachelor's degree in Engineering or equivalent;
工程学士学位或符合同等要求；
§ 5-6 years of quality and gage control experience preferred.
5到6年质量及量具管理经验；
§ Computer literate and general PC use required, office software / planning a plus.
必需的电脑使用技能如办公软件等；
§ Ability to define problems, collect data, establish facts, and draw valid conclusions.
具备分析，收集数据，建立事实和进行总结的能力。
Personal Traits (Will Do Criteria)
个性特征（使得将来可以发展去执行一些工作）
§ Professional and ethical conduct
专业及道德操守
§ Committed to strive for excellence in the execution of required responsibilities
致力于不断追求优秀的工作成绩
§ Committed to continuously improve English communication skills and cultural awareness
致力于不断改善英语沟通技巧和文化意识
§ Committed to continuously learn as needed to perform the required responsibilities
致力于不断学习职位所要求的执行力及必要的责任；
§ Learn the regulatory requirements for the Medical Device Industry
学习医疗行业的法规要求

Job Environment
工作环境
§ Hi tempo, high pressure in a multi-cultural environment with real challenges
富有挑战性的快节奏、高压力的多元文化工作环境中
Contacts/Involvement:
内/外部联系：
§ Liaison with other BIOMET manufacturing sites in China, USA and Europe
与中国，美国和欧洲的其它巴奥米特公司联系
§ Co-ordination and communication with vendors/suppliers and other functions in China facility
与供应商及国内工厂其他职能部门协调和沟通

Job Satisfaction Potential
工作潜在满意度
Satisfaction
满意度:
§ Opportunity to set up a world-class manufacturing unit from the beginning. Set the standards for BIOMET companies to follow.
有机会参与建立一个世界级制造基地，为巴奥米特公司制订各项标准并予以遵守
§ Opportunities for further career development.
有机会得到进一步的职业发展
§ Making friendships with Biomet members from around the world.
能与全球巴奥米特公司成员建立起友谊
Potential Dissatisfaction
潜在的不满意度:
§ Language
语言
§ Balancing cultural, deadline, production and quality challenges
文化差异的平衡，期限、制造和品质上的挑战

Development Perspective
发展方向:
§ An Opportunity to further develop ones technical, cultural, communication and management skills, in a controlled project environment of the highest visibility and importance. Some potential for assuming shift supervisor role on occasion.
有机会进一步发展个人技术，文化，认知、沟通和其它个人能力.


Authorities:
权限：
§ Entitled to stop and correct any action that is against quality.
有权组织并纠正任何违反质量的行为。
§ Entitled to lead and direct QC and metrology lab team members, in order to facilitate all aspects of quality control.
有权领导并指导QC及计量室团队便利质量控制。
§ Entitled to evaluate the quality control and metrology lab team member’s performance
有权评估QC及计量室团队成员的绩效。
§ Entitled to audit and approve relevant documents.
有权审核并批准相关文件。