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.