【Main Responsibilities】
• Establish software testing plans to deliver quality for medical software intended uses, safety, and security
• Responsible for developing and maintaining software testing pipelines for automatic or manual testing to improve software quality
• Responsible to review software tool validation to ensure the tools used in product development, test and operation processes are fully validated to fulfill intended uses
• Align with customer quality governance model for design & development projects
• Provide guidance to project team members on processes & template requirements, and reviewing software design deliverables
• Bachelor's degree or higher in Computer Science or Engineering
• 2+ years in a Software/firmware Development Quality Assurance role
• Fluent in C/C++, or C#, python programming language
• Experienced in building up software system/functional/integration test cases and analyzing architecture/module interaction between software components
• Experienced in development Quality/testing role in medical device industry is a plus
• Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (EU:MDR, IEC62304, ISO13485, ISO14971, UL2900) is preferred
• Result oriented, Team player, pragmatic & pro-active
• Good at English listening/speaking/reading/writing
瑞健集團(SHL)成立於1989年,目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今,在全球製藥及生物科技領域,SHL已成為藥物輸送系統的OEM/ODM領導製造商,如自動安全注射器。除此之外,SHL還擴展許多產品線,像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等,目標市場為北美、歐洲及亞洲。
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
* 承諾 Commitment
對客戶的承諾是我們成功的基石。我們致力提供客製化且全方位的解決方案來滿足客戶的個別需求。
Commitment to our customer is one of the cornerstones of our success. SHL strives to provide solutions that have been fully customized to meet individual customer requirements.
* 品質 Quality
品質保證是我們的基本原則,也是生產製程的核心部分,高品質的產品是SHL Group對客戶的保證。
Quality at SHL is a fundamental part of our organization and is built into the core of processes. This ensures that the products we manufacture meet customer requirements without compromise.
* 專業 Professionalism
我們在各階段的商業合作關係中皆秉持一貫的專業性,此為SHL Group在亞洲成為國際級製造商的主因。
Professionalism throughout every stage of our business relationships is one of the primary reasons that SHL has such a strong reputation as a world-class manufacturer in Asia.