Software Quality Supervisor
Carl Zeiss AG
Date de publication :
15 août 2024Taux d'activité :
100%- Lieu de travail :Shanghai
- Define the Software Quality tasks in the China team and actively follow up its implementation and application.
- Be responsible for QMS management and assure the retention of software development deliveries in DCC.
- Be the key person leading all quality assurance tasks for the software development project.
- Demostrate knowledge of and conduct training to software team on the company procedure, SOP and WI.
- Generate document review report before each gate according to software development procedure.
- Review and approve documentation from software quality perspective, supervision of process compliance during software development.
- 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 software quality is in question.
- Other duties, as assigned.
Education / 教育背景
- A Bacherlor degree or above with major in computer science and technology or software engineering is required.
Experience / 经验
- More than 2 years of experience in software quality management and implementation, with more than 4 years of experience in software development.
Other skills / 其他技能
- Good commuincation skill with ability to lead, convince and enforce.
- Proficient in the procedure of design development, design change, verification and validation.
- Familiar with the establishment and implementation of software quality management system.
- Experience in working under a quality management systems (QMS) for medical devices.
- Have knowledge of ISO 9001, ISO 13485 and NMPA regulations.
- Familiar with IEC 62366, IEC 62304, YY/T 0664 Medical device software Software life cycle processes.
- Being fluent in English written and verbally is essential.
- Be willing to take challenge and learn quickly.
Contact
Carl Zeiss AG