Be the key person leading quality assurance tasks for the project team in R&D.Leading the team, be responsible for QMS management.Define the QA tasks in the China team together with the project Quality Assurance from other company locations abroad, and actively follow up its implementation and application.Demostrate knowledge of and conduct training to project team member on the company procedure, SOP and WI.Generate document review report before each gate.Review plans and reports according to design and development process.Supports the generation and implementation of a product development process with emphasis on the design phase.Coordinates the document transfer from R&D into the document control of the corresponding Quality System of the company and/or Business Units in other locations.Participate in internal audits, coordinate the external audit including preparation execution, and communication of audit plan, audit reports, and follow up on audit findings.Take initiative and make sound decisions within the guideline provided, and is willing, if necessary, to stop a procedure or process when SOP or product quality is in question.Other duties, as assigned.

Education / 教育背景

A Bacherlor degree with major in Engineering is required. A higher degree is desirable and may substitute some years of experience.

Experience / 经验

At least 5 years of Quality Assurance work experience in a R&D environment with 3 years working at team leading position in Medical Device Industry.

Other skills / 其他技能

Strong leadership skill with ability to lead, convince and enforce.Proficient in the procedure of design development, design change, verification and validation.Skills in FMEA, Risk Analysis, Design Review, Verification, Validation etc.Be willing to take challenge and learn quickly.Being fluent in English written and verbally is essential.Experience in working under a quality management system (QMS) for medical devices.Have knowledge of ISO 9001, ISO 13485 and NMPA regulations. MDR and IVDR will be a plus.Good documentation and communication skills.Some occasional travel abroad might be needed.

Recruiter:

Anna Wang （王琼）, Magin Yang （杨晓君）