上海招聘

职位描述：
Senior Quality Engineer
Goal of function:
Design Assurance Control for design development project of PEC.COM to make sure all the development activities strictly follow up CDC QMS requirements and products developed are regulatory compliance.
Support QMS Management, the target will be to establish a design control system to enable efficient product development across the different international teams. The quality system has to be aligned with the global R&D development process and be embedded within the regional quality system.
 Main tasks
? Responsible for driving quality related projects, including but not limited to establishing and improving and optimizing of design controls. Manage quality related project with regards to timeline, scope, budget, and quality targets.
? Provide design Quality Assurance in project team as assigned.
? Responsible for CFDA license application support, specially focus on R&D preparation of GMP inspection, design transfer, DHF completeness, etc.
? Cooperate closely with GMQ partners and support to produce a good quality product in GMQ site.
? Responsible for the preparation of internal and external audit.
? Establishing positive and professional team culture within the team.
 Secondary tasks:
? Proactively driving project progress for successful delivery.
? Tracking and reporting of project progress.
? Providing professional knowledge and experience to support product registration.
Miscellaneous tasks:
? Coordination across multiple sites and locations.
? Support other QMS tasks assigned by Quality Manager.
? Closely with project teams, gather relevant information, report status.
Required skills:
1.Bachelor degree level up in Science or Engineering
2.5 years or more related experience like project design assurance and QMS management in active medical device company.
3.Experience on supplier quality management is a plus.
4.Experience and discretion working confidential and/or sensitive materials is essential
5.Good communication skills
6.Have the knowledge of CFDA, ISO 13485, MDD and related regulations.
7.Good written and oral English skill
Special personal requirements:
? Self-initiated
? Strong sense of responsibilities and take ownership
? Helpful, customer-oriented, stable emotion, easy integrate into the team
? Has good communication skills.
? Pay attention to quality and details 举报 分享

费森尤斯医药研发（上海）有限公司诚聘