Quality Engineer II – Medical Devices

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

• Maintain compliance with ISO 13485, 21 CFR Part 820 and other cGMP regulations.
• Lead investigations of non‑conformances, perform root‑cause analysis and drive corrective and preventive actions (CAPA).
• Oversee the non‑conformance material (NCM) process and ensure timely closure of TrackWise problem reports.
• Review and approve part qualification packages and supplier change requests.
• Conduct internal audits and support external regulatory inspections.
• Collaborate with cross‑functional teams to implement continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Life Sciences, Engineering, Chemistry or a related technical field.
• Minimum 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology.
• Strong analytical, problem‑solving and communication skills.
• Ability to work independently and as part of a team.

Required skills

• Knowledge of ISO 13485 and FDA regulations (Lead Auditor certification is a plus).
• Experience with quality tools such as risk management, CAPA, change control and statistical analysis.
• Proficiency in quality management software (TrackWise, SAP QM) and Microsoft Office suite.
• Experience conducting audits and supporting regulatory inspections.