Job Responsibilities

1. Contributes as a core team member of product development teams representing the QA function throughout the Product Development Process. 2. Key tasks lead by QA: - Risk management plan, risk analysis, risk management reports based on ISO14971 - CTQ. - Quality Plans. - Customer complaint historical data - Quality system for design and development 3. Performs: - Support other design and development tasks, such as FMEA (Design, Process, and Application), Process validation, Measurement Systems Analysis, Design verification and validation etc - Review and approve design documents and change control as core team member - Work with Mfg QE for product successful transfer. - Maintain quality system for design and development 4. Contributes to the successful completion of Process Validation initiatives: - Participate in pilot line set up and trial run. - Participate in the preparation of IQ, OQ, and PQ protocols and report - Perform statistical analysis of process data; interpret, compile and organize results and reports. 5. Lead non conformance report and CAPA 6. Ensures that all tasks are conducted in accordance with Quality System procedures. 7. Collect, analyze and interpret statistical data. 8. Performs analysis and provide reports to management as required. 9. Involve in QMS improvement and internal audit. 10. Improve quality culture in project team. Provide QA training and case sharing with project team.

Job Requirements

- Minimum three (3) years’ experience in design quality assurance or quality engineering position (medical device experience preferred). - Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, Risk management, Reliability test, Failure Mode and Effects Analysis. - Experience in a regulated environment (ISO,MDD etc.) is preferred - BS/MS is preferred in Material, Software, Mechanical or Electrical engineering background - In fluent English in both written and oral. - Good computer skill of Microsoft application software

Required Languages

English