Quality Engineer II

About the role

Thermo Fisher Scientific is seeking a Quality Engineer II to join its Quality Assurance team. In this role you will ensure compliance with quality standards and regulatory requirements across manufacturing operations, supporting the company’s mission to make the world healthier, cleaner and safer.

Key responsibilities

• Perform incoming inspection and in‑process quality control (IPQC) testing for array and instrument manufacturing.
• Review and disposition inspection records in line with ISO 13485 and other regulated guidelines.
• Participate in continuous‑improvement activities such as 5S, LEAN, Kaizen, VSM and RCCM.
• Support method transfer, method validation and development of new testing procedures.
• Maintain laboratory equipment, manage inventory and ensure timely updates on test results.
• Lead investigations, trend analyses and CAPA implementation for raw material and reagent failures.
• Coach and mentor junior staff, providing performance management as needed.

Required profile

• Degree in biochemistry, life science, chemical engineering or equivalent.
• Minimum 2 years of QA/QC experience, preferably in medical device or biotech industries.
• People‑management experience is a plus.

Required skills

• Knowledge of ISO 13485 requirements.
• Experience with LEAN and continuous‑improvement tools (5S, Kaizen, VSM, RCCM).
• Ability to conduct CAPA investigations and implement corrective actions.