QE - (Senior) Design Quality Engineer
有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門，我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是，希望能大量減少產品走到量產的階段才發現問題來進行補救，而是在開發設計階段就針對品質去把關。
在醫療器材產業中，品質絕對是擺在第一位，因此品質團隊在SHL非常重要，甚至可以影響設計師、客人的想法！2025年部門擴大招募中，歡迎所有對於堅守產品品質有興趣的工程背景人選。
【Job Overview】 The Senior Design Quality Engineer is responsible for supporting new product development, process development and product care through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product/process inception through product launch, scale-up and maintenance with an active role in the processes to ensure products meet quality standards which are consistent with Customer Requirement, while meeting all design controls and regulatory requirements, including but not limited to FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 11608 & ISO 14971.
【Main Responsibilities】 • Represent Quality on new product/process development and product care projects. • Ensure design controls process of the projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assess and approve the risk mitigation techniques implemented and confirm consistency with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – Failure mode and effects analysis, especially DFMEA • Develop quality controls and work closely with Quality Assurance Team on the transfer of quality requirements. • Promote the use of statistics during investigations and evaluations to provide concrete supporting evidence towards decisions. • Support Device product/process development and production activities, including the following: - Review product/process verifications/validation test plans (protocols and reports). - Develops or reviews product/process specifications and requirements. - Develops or reviews product reliability specifications/predictions, reliability test activities. - Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, - Participates in product or process design and change activities, including design reviews, change control board meetings. - Provides technical support for product quality attributes/decisions. - Support selected verification/validation activities (e.g., toxicology/biocompatibility, sterilization validation, etc.)with external suppliers. • Contribute to compilation and maintenance of Design History Files (DHF). • Ensure proper design and development documentation as per ISO 13485/FDA QSR Quality System
【Required Skills & Qualifications】 • 5+ years of work experience in Product Design and Development or Design Assurance in regulated environment (medical devices/Diagnostic instrumentation industry, electronic consumables, pharmaceutical or biotechnology industry). • Demonstrated ability to work effectively with Design Team, Process Development, Regulatory, and Quality teams. • Effective communication skills to convey complex quality and design principles to diverse stakeholders. • Experience in implementing and managing Design Control processes and ensuring compliance with regulatory standards throughout the product lifecycle with comprehensive understanding of medical device regulations such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971. • Familiarity with design verification, validation, and usability testing principles. • In depth know-how and experience of quality techniques: Six Sigma Blackbelt, Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc. • Experience in Design for Manufacturing and Assembly, ability to review tolerance analysis, and knowledge over structural and part simulation. • Experience using statistical tools and methods for data analysis and process optimization.