招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
In this role, you have the opportunity to
?Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.
?Supervise NPI (New Project Introduction) project, and implement design controls requirement into NPI.
?Concentrate on CFR820.30 Design control and ISO13485, EU MDD/MDR, MDSAP, ISO 14971 Risk Management, IEC62304 Software development lifecycle and any other regulation/standard applied to medical device.
You are responsible for
?Be responsible for the design control in NPI/Sustaining Project Quality Assurance.
?Work as part of project teams to lead the project quality by ensuring the process compliance through project involvement and project deliverables review
?Working with these cross-functional groups, develop Project Quality Assurance Plan, and lead their implementation.
?Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30 and ISO13485. Drive project decision direction toward compliance, cross functionally and globally.
?Ensure that program documentation (Design History File) is created, controlled and archived in accordance with the Quality System.
?Conduct the project process audits and consultant as needed to support project team for the project deliverables
?Handle project related noncompliance accordingly
?Find the improvement opportunity during project quality assurance and initialize the improvement.
?Be expert of design control
?Lead Design Control process improvement and maintenance and Support QMS manager to promote Quality Culture
?Provide the process training to required trainees
?Lead, prepare and participate/be main escort in internal and external audits (e.g. FDA, CFDA, TUV, JPAL, KFDA, MDSAP, etc)
?Facilitate CAPA when design control related.
You are a part of
Reporting Relationship
?Directly reports to Senior QA Manager
Work relationship
Internal: major functions such as R&D, manufacturing, purchasing etc
External: regulatory agencies such as US FDA, China CFDA and notify bodies such as TUV
To succeed in this role, you should have the following skills and experience
?BS/MS in Engineering or equivalent experience
?Strong quality assurance management experience, minimum 5 years in quality assurance
?Strong design control and new product development experience
?Strong statistical and analytical abilities.
?Strong communication, problems solving and continuous improvement.
?Fluent English both in writing and speaking.
?Have experience in medical industry
?Strong Influence Skill, Presentation Skill and Dispute solving Skills.
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