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 Quality Engineer of Process - Molding&Tooling 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 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, ISO 13485, ISO 11608 & ISO 14971.

【Main Responsibilities】

• Team member representing Quality on new product/process development and product care projects.

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

• Assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA.

• Develop quality plans and work further with Manufacturing on the transfer of quality requirements.

• Promotes the use of statistics in the testing and control of quality.

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

- Develops or reviews product/process verifications/validation or 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,

- fault tree analysis (FTA) and/or risk or statistical analysis.

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

- Provides technical support for product quality attributes/decisions.

- Support selected verification/validation activities (e.g., toxicology/biocompatibility, 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