北京招聘

Responsibilities:
1.Implement & Maintain Quality System Processes and Procedures.
2.Materials Review Board and CAPA Documentation.
3.Implement and Maintain an Effective CAPA Process.
4.Conducts mechanical and process QA engineering activities of significant scope or degree of difficulty (medium-large component/system/process associated with a medium to large project). Performs most assignments independently, with only general supervision/instruction as to expected results.
5.Maintains communications within and outside of department in support of quality systems engineering activities, such as project management meetings, material review, etc. Actively participates in and contributes to the decision-making process; often conducts the meeting or presentation, and makes follow-up assignments for team members.
6.Oversees preparation of documentation associated with quality systems engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures, etc.
7.Implement and Maintain an Effective Internal Audit Process.
8.Assist the RQS Manager with Coordinating Product Recalls.
9.Provide QS Systems Support for all Complaint handling activities conducted by Operations and Global Complaints Team
10.Perform other responsibilities as directed by the Regional Quality System Manager.

Technical Knowledge and Skills:
Bachelor's degree from an accredited college or university, or an equivalent education. Three to five years direct experience in a medical device industry or regulated company or similar environment with Quality Systems Experience in GMP and ISO quality system standards. ISO 9001, ISO 13485 assessor very desirable.

KNOWLEDGE
?Trained in Quality System Regulation and documentation techniques. Trained in Quality Management Systems, SFDA, ISO 9001, ISO 13485, and 21 CFR 820, Internal Auditor Lead Assessor training.
?Good understanding of CAPA systems and implementation.
?Understanding of medical device industry and products.
?Knowledge and skill in engineering documentation procedures, development methods and project management.
?Knowledge of Statistical Process Control (SPC) and quality tools including sampling, tables, and CPK; ability to design and perform required tests using appropriate tools.
?Knowledge of computer hardware, personal computers, and single purpose embedded micro systems.

SKILLS
?Planning skills to develop quality systems plans, policies/procedures, and systems to meet standards and business requirements.
?Demonstrated excellent verbal communications skills and technical writing ability. Able to plan and conduct effective meetings and group presentations. Able to provide technical presentations to internal and external audiences.
?Skill in developing training programs to meet individual and group needs.
?Excellent interpersonal skills to interface with all levels of company structure as well as representatives of outside agencies or companies.
?Ability to assimilate regulatory publications and convey their principles and practical effects to the organization.
?Good leadership skills.
?Good decisions making and problem solving skills
?Demonstrated flexibility and resilience in the face of constraints, frustrations or adversity.
?Demonstrated effective analytical and problem solving skills to identify root causes and appropriate solutions quickly.

史密斯医疗是一家全球领先的医疗设备和器材供应商，它的产品广泛应用于医院，急救，家庭护理，专科医院及兽医,总部设立在英国,伦敦.

超过60年的信赖，史密斯医疗的丰富产品线为患者提供了全面和持续的治疗手段。
从常见的输注系统和创新的输液泵技术，到聪明的管理系统和患者监护及诊断设备，史密斯医疗的先进技术已经为可靠和高质量治疗的解决方案指定了标准。
史密斯医疗市场领先的产品线由12个值得信赖的品牌带领，这些品牌早已被临床医生广泛熟知和信任。
史密斯医疗承诺，通过提供高品质、高性价比的产品，帮助临床医生照顾那些依赖这些产品进行药物输注、提供生命维持的患者，并保障安全使用。

http://www.smiths-medical.com
电子邮箱： resume@smiths-medical.com

办公室地址：
上海：上海市静安区延安中路1228号,静安嘉里中心办公楼3座28层200040
北京：北京市朝阳区光华路1号北京嘉里中心南楼30层3018单元100020
杭州：浙江省杭州经济技术开发区3号大街26号310018
上海研发：上海市浦东新区张江高科技园毕升路299弄9号102室201204