Senior Engineer, QA

Drive and support an effective quality management system for mass volume manufacturing from new program introduction to sustaining manufacturing which meets the requirements of quality management standards such as ISO9001 and/or ISO13485, quality system regulations, relevant products regulatory and customer requirements.

Responsibilities

• Support the Quality Manager in managing daily quality assurance activity to ensure the out-of-factory product quality
• Support NPI, risk management, validation qualification, production part approval process activities and its documentation to meet predetermined requirements
• Establish & responsible for generating quality guides or documentation to train quality technicians and/or production operators
• Ensure timely review & proper maintenance of device history records (DHR) in accordance with the requirements of ISO13485, customer & relevant regulatory requirements
• Engage customers and/or suppliers on matters relating to product quality issues
• Drive continuous improvements activity through 8-D discipline, CAPA or equivalent tools
• Support internal, 3rd party or customer quality system and/or process audits
• Drive internal MRB meetings for proper disposition and control of non-conforming materials
• Support internal ECR meetings for proper change control process
• Responsible for data collection and reporting quality performance in management and customer reviews
• Undertake continuous improvements projects and/or assignments dedicated by the management
• Undertake supervisory role to provide necessary guidance to quality technician or engineer.

Requirements

• Diploma or Basic Degree in Quality Assurance, Science, Mechanical Engineering or equivalent
• Minimum 5 years relevant quality function work experience in a manufacturing environment
• Good understanding of quality management system requirements (e.g ISO 9001 and ISO13485) and/or 21CFR Part 820 QSR
• Familiar with statistical analysis & applications using Minitab software
• Familiar with risk management process tools such as PFMEA
• Able to work independently and has good communication skills

If you embody the spirit of excellence, passion for discovery, innovation and enterprise, and the desire to make a difference in the world of technology and electronics, come join the Venture team!

Be Part of the Global Venture Family.

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