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 an...