QA Engineer – Product Quality

About the role

Thermo Fisher Scientific is seeking a QA Engineer focused on product quality to ensure compliance with regulatory standards across manufacturing operations. You will work within a collaborative environment, driving continuous improvement and supporting product qualification initiatives.

Key responsibilities

• Maintain compliance with cGMP, FDA, ISO 13485, MDSAP, IVDR, ISO 9001, ISO 14001, ISO 45001 and other applicable standards.
• Lead investigations, perform failure analysis, and implement corrective and preventive actions (CAPA).
• Manage end‑to‑end complaint handling, including review, escalation, trend reporting and resolution of product and transportation quality issues.
• Support new product introduction (NPI), transfer projects, supplier quality, material review board (MRB), change control, deviations and risk management.
• Conduct internal audits and assist with external regulatory inspections.

Required profile

• Advanced degree with no experience, or Bachelor’s degree plus at least 2 years of QA experience in GMP/ISO regulated environments (medical devices, pharmaceuticals or biotechnology preferred).
• Strong documentation and technical writing skills for SOPs, protocols and reports.
• Ability to work independently and collaborate across functions, with strong attention to detail.

Required skills

• TrackWise and SAP QM quality management software.
• Microsoft Office suite.
• Statistical analysis tools and quality metrics reporting.
• Risk management, root cause analysis, CAPA and change control methodologies.
• ISO 13485/FDA Lead Auditor certification (beneficial) and ASQ CQE/CQA certifications (advantageous).