Responsibilities

1. Conduct hands-on failure investigations of returned instruments and parts from customers to find the root cause of failures.

2. Document investigation findings in failure analysis report.

3. Drive RMA process and ensure minimum turn-around time for instrument failure analysis.

4. Support quality improvement activities and provide corrective action recommendations.

5. Handle returned and used devices in compliance with company policies.

6. Support company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.

7. Support Product Quality Engineer in handling inter plant raw material RMA and drive for corrective action.

8. Support plant-wide activities and special projects as assigned.

Qualification

1. Diploma Holder in engineering discipline or 3-5 years with relevant experience for ITE graduates

2. Excellent analytical skills and good written and verbal communications skills necessary

3. Working knowledge of international quality standards (ISO9001, ISO13485, 21 CRF Part 820) preferred

4. Able to work independently with flexibility to adjust to changes priorities

5. Must possess a strong desire for hands-on work in a FA Lab environment.