[DET QARA] Software Quality Engineer

【About Us】

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

【In this role, you can】

Ensure full compliance, and solid product & process quality on design assurance of digital platform, software as medical device, health informatics and software component.

【Main Responsibilities】

• Design, implement, and document automatic or manual software verification plans to ensure product or in-house software quality meets the requirement specifications and medical software regulations,

• Create, maintain, validate related tools used in hardware/software verification activities,

• Identify software quality risks & process gaps and drive mitigation,

• Provide guidance to project team members on SDLC processes & template requirements, and review software design deliverables,

• Study related medical device standards/guidance and drive department improvement

【Required Skills & Qualifications】

• Bachelor’s degree or higher in Computer Science or Engineering

• 2+ years in a Software/firmware Development Quality Engineering role

• Fluent in python and with libraries of unittest, RestfulAPI, selenium, pyautogui

• Experienced in building up automated software system, end-2-end, database testing (SQLite, MongoDB, MySQL, etc.)

• Experienced in code version control tool (e.g. Git), and in project management tool (e.g. JIRA, Azure)

• Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (IEC62304, ISO14971, UL2900, GAMP-5) is preferred

• Result oriented, Team player, pragmatic & pro-active

• English speaking/reading/writing