QE - Senior Quality Engineer (Product Design/Process Design)

작업 내용

Job Overview

The 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 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

Required Skills & Qualifications

Education:Technical / scientific degree at college / university level (mechanical, industrial, biomedical, chemical engineering, material/life science)

Experience_Occupational experience

• At least five years’ work experience in a Product Development/Design Assurance function in regulated environment (medical devices/Diagnostic instrumentation industry, pharmaceutical or biotechnology industry.)
• Experience in the design and development of products in accordance with ISO 13485 guidelines.
• In depth know-how and experience of quality techniques: Six Sigma Blackbelt, Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc.
• Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testings
• Experience in the entire Design life-cycle and Phase-Gate development process.

Experience_Special knowledge, expertise, experience

• cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
• Statistical methods
• SAP (Manufacturing Execution Systems / MES will be an advantage)
• English (spoken and written), local language (Mandarin) is a plus