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DET QARA - Software QA Engineer (306)

Shl Medical
On-site
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.

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【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.

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【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.

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【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).