Quality Engineer - Singapore - Venture Corporation Limited

Venture Corporation Limited

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

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JOB SUMMARY

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

JOB RESPONSIBILITIES

Support the Quality Manager in managing daily quality assurance activity to ensure the outoffactory 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 8D 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 nonconforming 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

DESIRED / PREFERRED QUALIFICATIONS

Diploma or Basic Degree in Quality Assurance, Science, Mechanical Engineering or equivalent
Minimum 2 years relevant quality function work experience in a manufacturing environment

DESIRED / PREFERRED SOFT SKILLS

Good understanding of quality management system requirements (e.g. ISO 9001 and ISO13485) and/or 21CFR Part 820 QSR
Familiar with risk management process tools such as PFMEA
Able to work independently and has good communication skills