体系工程师 Quality System Engineer
上海任仕达人才服务有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-04-27
- 工作地点：苏州
- 招聘人数：若干
- 职位类别：体系工程师/审核员
职位描述
任职要求： Education
Bachelor degree or above with a medical device or pharmaceutical background.
Experience
1. A minimum 5 years experience in a quality / regulatory environment with 2 or more years in Research and Development quality area.
2. Multinational company experience is a plus.
Skill / Knowledge / Abilities
1. Familiar with GMP, GLP, QSR, MDD, ISO, 510K, etc.
2. Knowledge of In Vitro Diagnostic products.
3. Good command of English and Mandarin both verbal and writing.
4. Problem solving and priority setting.
5. Self-motivated, initiative and able to work under pressure.
6. Interpersonal skills and the ability to work effectively within diverse cultural environments.
职位职责： 1. Lead Research and Development team into compliance with Design Control procedures.
2. Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
3. Ensure robust verification, validation, product designs and design review processes are established.
4. Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems.
5. Provide guidance to Research and Development team on compliance with requirements for ISO 13485, European MDD, FDA / QSR, & SFDA regulations.
6. Provide support for stability studies during design phase.
7. Provide support for change control assessment to define applicable design control elements are carried out.
8. Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & Control Plan etc.
9. Partner with regulatory team for initial regulatory review in support of design change requests.
10. Maintain system and provide oversight of design team activities to identify critical-to-quality design features and ensure adequate control plans for product and process designs to demonstrate product is ready to market & manufacture on an ongoing basis.
Bachelor degree or above with a medical device or pharmaceutical background.
Experience
1. A minimum 5 years experience in a quality / regulatory environment with 2 or more years in Research and Development quality area.
2. Multinational company experience is a plus.
Skill / Knowledge / Abilities
1. Familiar with GMP, GLP, QSR, MDD, ISO, 510K, etc.
2. Knowledge of In Vitro Diagnostic products.
3. Good command of English and Mandarin both verbal and writing.
4. Problem solving and priority setting.
5. Self-motivated, initiative and able to work under pressure.
6. Interpersonal skills and the ability to work effectively within diverse cultural environments.
职位职责： 1. Lead Research and Development team into compliance with Design Control procedures.
2. Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
3. Ensure robust verification, validation, product designs and design review processes are established.
4. Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems.
5. Provide guidance to Research and Development team on compliance with requirements for ISO 13485, European MDD, FDA / QSR, & SFDA regulations.
6. Provide support for stability studies during design phase.
7. Provide support for change control assessment to define applicable design control elements are carried out.
8. Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & Control Plan etc.
9. Partner with regulatory team for initial regulatory review in support of design change requests.
10. Maintain system and provide oversight of design team activities to identify critical-to-quality design features and ensure adequate control plans for product and process designs to demonstrate product is ready to market & manufacture on an ongoing basis.
公司介绍
www.randstad.cn
联系方式
- 公司地址：梅园路77号
- 邮政编码：200070