DET QARA - Software QA Engineer

SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

【Job Overview】

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

【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

【Qualification】

• Bachelor's degree or higher in Computer Science or Engineering
• 2+ years in a Software/firmware Development Quality Engineering role
• Fluent in python and and have experience in serial port, BLE, IoT verification activities
• 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