长沙招聘

职位描述：
Company Profile
Carbo-Fix Orthopedic Ltd., is a fast growing company, engaged in developing, manufacturing and marketing of innovative solutions for the fixation of long bones fractures.
The company uses its cumulative knowledge and expertise in the field of orthopedics to develop products which enhance the quality of life of patients and are more user-friendly for surgeons.
For our new operation in China, we are looking for candidates for the position of QA Supervisor, with the details below:

Job Description:
QA supervisor is responsible for development and implementation of organization’s quality strategy and manage the quality system to achieve company goals.
The QA supervisor should have the knowledge for performing the function within China Food & Drug Administration (CFDA), Quality System Regulations (QSRs),
GMP factory under China medical device quality management system(QMS), to achieve Medical Device Manufacturing License by CFDA for manufacturing site.
QA Supervisor should be familiar with International Organization of Standardization (ISO) 13485:2003, and Medical Device Directive (MDD), to support products export.

Responsibility:
? Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
? Develop and implement quality control and inspection procedures for incoming materials, in-process materials and final product acceptance activities.
? Define quality control standards and tests; specify test equipment and procedures.
? Establish and maintain test instrument calibration procedures and maintenance schedules.
? Establish quality assurance and quality control inspection and testing procedures.
? Prepare and maintain all documents of quality system to cover all procedures, SOP, (Standard Operating Procedures), forms and company quality policy.
? Identify quality assurance metrics; analyze and report trends to management.
? Review and host meetings for nonconforming materials.
? Developing and maintaining sterilization validation and material biocompatibility activities.
? Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations.
? Assist in the failure investigation of product complaint and CAPA activities.
? Serve as Lead Auditor; manage all internal audits, prepare for registrar audits.
Communicate with auditing agencies, coordinate preparation for and conducting of regulatory agency inspections.
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Requirements:
? Bachelor’s Degree with a minimum of 4 years experience in the medical device industry.
? Demonstrated success in a start-up, entrepreneurial work environment
? Thorough knowledge of CFDA Quality System requirements, ISO 13485:2003 requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
? Understanding of sterilization validation and material biocompatibility requirements.
? Good verbal and written communication skills in English.
? Ability to work in a team minded approach to achieve individual and company success.
? Experience with government agency interactions and coordinating cross functional groups in the resolution of Operational compliance issues.

Location: Guangzhou, China.

We offer:
? Challenging position in intimate and dynamic work environment
? Development in a global enterprise, with innovative and unique technology.
? Independent work with professional and experienced team
? Competitive wage package and options for future development.

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。