Position Summary
该职位负责通过确保公司程序符合监管和ISO要求来维护SMCN的质量管理体系。负责质量方针和程序的管理。
This role is responsible for maintaining SMCN’s Quality Management System by ensuring company procedures comply with regulatory and ISO requirements. Responsible for the administration of quality policies and procedures.
Job Responsibilities
该职位负责但不限于以下工作：
This position is responsible for, but not limited to, the following:
质量管理体系（QMS）管理Quality Management System (QMS) Management:
- 维护公司质量管理体系流程和程序，以管理产品和监管要求
Maintains the company Quality Management System processes and procedures required to manage product and regulatory requirements
- 遵守行业法规和标准，包括NMPA和ISO 13485
Stays current with industry regulations and standards including NMPA and ISO 13485
- 主动识别持续改进的机会，有效解决质量相关问题
Proactively identifies opportunities for continuous improvement and effectively resolve quality related issues
审核管理Audit Management:
- 协调并准备监管部门、公告机构和主要客户的现场审核
Coordinates and prepares site audit from health authority, notified body and key customers
- 跟进审核响应，以确保问题得到适当调查和有效解决，并在规定的时间内提交审核响应
Follows up on the audit responses to ensure the problems are properly investigated and effectively addressed, and the audit responses are submitted within the required timelines
CAPA和不合格控制CAPA and Nonconformity Controls:
- 管理和维护纠正和预防措施（CAPA）和不合格（NC）过程的有效和稳健控制，以确保产品的安全和质量
Manages and maintains the effective and robust controls of Corrective and Preventive Action (CAPA) and Nonconformity (NC) processes to ensure the safety and quality of the products
- 定期或根据需要多频次举行CAPA审查委员会会议，并在会议前准备审查数据
Holds the CAPA Review Board meeting on a regular basis or frequently as needed and prepares the review data prior to the meeting
- 在CAPA处理过程中，指导和协助跨职能团队进行调查、实施和有效性检查阶段
Guides and assists the cross-functional teams with the investigation, implementation and effectiveness check phases during CAPA handling process
- 支持NC负责人在NC处理过程中的调查、实施和处置活动
Supports the NC owner on the investigation, implementation and disposition activities during NC handling process
- 监控CAPA和NC过程的绩效指标，并在需要时进行任何升级
Monitors the performance metrics of CAPA and NC processes and makes any escalations when needed
其他Others:
- 遵守安全规则，维护人身安全和他人安全，包括维护干净安全的工作区域
Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area
- 按要求准确记录和报告信息
Accurately records and reports of information as required
- 遵守公司内部的员工政策
Follows employee policy within the company
- 可能会被分配、指导或要求其他工作
Other duties may be assigned, directed or requested
资质Qualifications
- 工程和/或制造相关领域学士学位优先
Bachelor’s degree in engineering and/or manufacturing related fields preferred
- 必须在医疗器械制造领域拥有5年以上的质量管理经验
Must have 5+ years of quality management experience in the medical device manufacturing field
- 有2年以上CAPA处理经验者优先
More than 2 years in CAPA handling process preferred
- 熟悉NMPA医疗器械法规和ISO13485:2016
Familiarity with NMPA medical device regulations and ISO13485:2016
- 对医疗器械整个生命周期的设计、生产和质量控制有深入了解
In-depth knowledge of design, production and quality controls throughout the lifecycle of medical devices
- 必须能够利用基本的质量工具，包括RCA、鱼骨分析、SPC、检查表、直方图、帕累托图、散点图、过程映射和流程图
Must be able to utilize the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
- 必须能够生成质量文件，如起草管理评审、规定时间内的关键绩效指标、质量体系的风险管理和正式程序/作业指导
Must be able to produce quality documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures / work instruction
- 在多个职能部门表现出团队合作、协作、良好的口头和书面沟通技巧
Demonstrated teamwork, collaboration, good oral and written communication skills across multiple functional groups
- 流利的英语书面和口语表达
Fluent in both written and oral English
期望资质Desired Qualifications
- 有按订单生产和按库存生产的经验
Experience in make-to-order and make-to-stock manufacturing.
- 熟悉FDA和其他国际医疗器械法规
Familiarity with FDA and other International medical device regulations
- 认证的主任审核员或内审员优先
Certified Lead Auditor or Internal Auditor is preferred
- 过程确认经验
Process Validation experience
- 产品质量控制经验
Product quality controls experience
About Straumann
The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.
Headquartered in Basel, Switzerland, the Group currently employs more than 7300 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners.
For more information, please visit: Straumann Group