Job Summary
The role reports to the Head of Quality and is supported by a Senior Quality Technician on the documentation.
The successful candidate will be responsible for maintaining the Document Control System, and Quality System Audit Program.
Responsibilities
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
Requirements
- 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
