Quality Engineer

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The Quality Engineer will be part of a cohesive team responsible for ensuring the quality of products and processes across all product lines and supporting compliance with the site’s Quality Management System. This role acts as the technical quality anchor for the site, focusing on product and process quality, supporting new product introduction (NPI), process validation, and lifecycle quality performance. The Quality Engineer will work closely with Engineering, Operations, and R&D to ensure robust process control, effective problem solving, and continuous improvement.

Support deployment and continuous improvement of the site Quality Management System (QMS), ensuring compliance with internal and regulatory requirements. Lead product and process quality activities across the lifecycle, including New Product Introduction (NPI), process validation, and First Article Inspection (FAI). Perform and maintain product and process risk analysis (FMEA, DFMEA, PFMEA), and provide technical input to investigations of non-conformances, audit findings, CAPA, complaints, and SCARs. Apply structured problem-solving methodologies to investigate and resolve product and process quality issues, including warranty claims and Out of Box Failures (OOBF). Develop and maintain quality documentation including control plans, Inspection and Test Plans (ITPs), Certificates of Compliance, and manufacturing data reports. Provide technical input on customer quality requirements and specifications during project execution and, where required, support tender discussions. Support supplier quality activities by providing technical input to supplier-related issues and improvement initiatives led by the Quality Specialist. Support change control, deviation management, validation activities, and in-process controls to ensure product and process compliance. Contribute to continuous improvement of quality processes, systems, and procedures, including requirement management, design transfer, and defect management. Support achievement of key quality KPIs including CAPA effectiveness, First Pass Yield (FPY), and product quality performance metrics. Collaborate with cross-functional teams (Engineering, Operations, R&D, Field Service) to ensure robust process control and continuous improvement. Remain current with relevant industry standards, regulatory requirements, and best practices. Support global quality initiatives and implementation of best practices at the site level. Other related tasks as required by management.

Bachelor’s degree in Mechatronics, Electrical, Electronics Engineering, or related discipline, or equivalent industry experience.

5+ years quality engineering experience within a manufacturing environment. Strong experience working in cross-functional teams (Engineering, Operations, R&D) to resolve product and process quality issues. Experience in structured problem-solving methodologies (e.g. 8D, Root Cause Analysis, Lean tools). Working knowledge of ISO 9001 quality management systems. Basic understanding of applicable regulatory and compliance requirements for electromechanical products (e.g. CE, ROHS) would be beneficial. Knowledge of manufacturing processes such as metal fabrication, assembly, or coating processes would be beneficial. Lead Auditor