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】

You will be responsible for ensuring software quality by creating, reviewing, and executing verification and validation plans for the electromechanical autoinjector product and its manufacturing test fixtures.

【Responsibilities】

• Create, review, and execute software validation activities (Performance Qualification) for the manufacturing test fixture.
• Evaluate the software design of the manufacturing test fixture through optimal means (Design Qualification).
• Involve in the Software Development Life Cycle (SDLC) process and review the software design deliverables.
• Create and execute manual and automated software verification activities of the electromechanical autoinjector product.

【Qualification】

• Bachelor's degree or higher in Computer Science or Engineering.
• Minimum of 2 years of experience in a Software/Firmware Development Quality Engineering role.
• Proficiency in Python, with experience in creating Python scripts.
• Experience using Python to work with serial ports, SciPy commands, and Wireshark is a plus.
• Experience working with DBMS (MySQL, PostgreSQL, SQLite, etc.) and the verification of it is a plus.
• Proficiency in code version control tools (e.g., Git) and project management tools (e.g., JIRA, Azure).
• Knowledge of applicable Medical Device Software Product Lifecycle and GxP standards (IEC 62304, IEC 80002-1, GAMP-5) is preferred.
• Result-oriented, team player, pragmatic, and proactive.
• Proficient in English (speaking, reading, and writing).