Translate software requirements / functional specifications into effective test protocols while ensuring consistency with regulated protocols and software requirements coverage.

Execute test cases and effectively compile, document, and analyze test results to assess product quality.

Identify, document, and track defects and work with developers to resolve those defects.

Ensure that all validation activities and customer deliverables meet regulatory guidelines.

Easily assimilates to new SW technologies.

Fluent in English (written and verbal).

Ability to translate regulated documents between English and Chinese (each way).

Accommodate working with both US and China team members.
Required qualifications

A minimum of six years relevant experience in a medical device structured software development environment.

Bachelor’s / Master’s degree (preferably computer science or a related field).

Experience writing formal verification and validation tests in a FDA-regulated environment.

Excellent oral and written communications skills.

Experience with US 21 CFR 820, 21 CFR Part 11, ISO 62304, and ISO14971 requirements.

Experience with Requirements Management SW.

Experience with Good Documentation Practice (GDP).

Experience with YY/T 0664-2020, YY/T 1843-2022 , GB/T25000.51-2016, GB/Z42217—2022, NMPA 2022 no.9, and NMPA 2022 no.7.

Highly desired experience with EU MDR.

其他信息
语言要求：英语
行业要求：全部行业