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！目前部門擴大招募中，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 Quality Engineer of Process - Automation&Assembly is responsible for supporting new process development, automation equipment development and product transfer 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, deployment and retrofit, and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all design control and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, 21 CFR Part11, ISO 13485, ISO 11608 & ISO 14971.

【Main Responsibilities】

• Represents Quality on process design, equipment development, and product transfer projects through Product Lifecycle.

• Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements.

• Assesses failure modes and approves the risk mitigation tool, techniques, good practices to ensure the risk management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level.

• Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise.

• Promotes the use of statistics in the pre-study, engineering investigation, and in-process control based on quality aspects.

• Supports Device product/process development and product transfer activities, including the following:

- Consolidates or reviews lessons learned and historical data to influence product design.

- Supports or reviews process/equipment specifications and requirements including system level.

- Supports or reviews process/equipment verifications activity (protocols and reports) and validation/test plans.

- Participates in product or process/equipment design and change activities, including qualification and reviews.

- Participates in risk management activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis.

- Provides technical support for product and process quality attributes/decisions.

- Support selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers.

• Contributes to compilation and maintenance of Design History Files (DHF).

• Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System.