Senior Engineer, Quality

5 hours ago


Ang Mo Kio, Singapore Venture Corporation Limited Full time

Job Summary

The role reports to the Head of Quality and is supported by a Senior Quality Technician on the documentation.

System Audit (Internal/Certification Body/Customer/Regulatory) Management

Lead and coordinate internal quality management system (QMS) audit, and internal environmental management system (EMS) audit
Prepare and coordinate for successful external audits from certification body, customer and regulatory factory inspections
Report to management on the NC findings, and coordinate the Root Cause and CAPA for timely closure
Arrange for awareness training on relevant Quality Management System topics

System Maintenance and Improvements

Maintain document control systems, to comply with ISO1348, ISO9001 and ISO14001 standards, regulatory and customer requirements
Ensure that document owners keep their documents up-to-date, accurate and easily accessible to employees who need them
Ensure that record owners retain their records, complying with applicable requirements
Support mapping of business process flow-chart, and assist document owners in creating their documents
Drive continuous improvements related to QMS and EMS, e.g. ESD Control compliance, Recycling rate improvement, e-Document Management improvement, e-Global Asset Management System (Calibration, Preventive Maintenance, etc) improvement
Working experience in the manufacturing industry (Electronics/Mechanical/Bio-Medical/Mechatronics), Life Science Instruments, and PCBA
Experience in supervision and a demonstrated track record in effectively leading team
**Knowledge in Quality Standard**: ISO13485, ISO9001, ISO14001, and FDA 21 CFR part 820
**Familiar with Regulatory Requirements**: RoHS, REACH, UL/ETL Product Safety labeling
Proficient in planning, executing, and leading Internal Quality Audits
Strong communication and coordination skills to facilitate External Quality Audits
Proficient in utilizing software tools such as Visio and Excel to map business process flowcharts
Skilled in delivering presentations to management regarding Quality Audit outcomes and status



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