Position Objective:
We are recruiting for a fixed term Quality Engineer. Join Thermo Fisher Scientific Inc. as a Quality Engineer II and contribute significantly to maintaining high-quality Systems in line with ISO13485 and FDA 21CFR Part 820. Your duties involve ensuring compliance with internal and external standards, leading data analysis, investigations, and enhancing processes for improved results.
Essential Functions:
1. Collaborate closely with Production, Technical, and Manufacturing Engineering teams to resolve quality issues from customer complaints and internal incidents. You will facilitate investigations and resolutions of these related quality issues.
2. Partner with technical support and manufacturing to develop and refine methods and procedures, ensuring processes, products, tests, materials, and manufacturing equipment meet required standards.
3. Aim to improve efficiency in procedures and processes without compromising quality. Identify and implement improvement opportunities across the operational facility.
4. Perform statistical analysis to determine trends, conduct root cause analysis, and lead corrective actions for processes and products.
5. Stay Informed of Regulatory and Quality System requirements (ISO13485/FDA CFR).
6.