Quality Assurance Supervisor
Carl Zeiss AG
Date de publication :
15 août 2024Taux d'activité :
100%- Lieu de travail :Shanghai
- 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)Contact
Carl Zeiss AG