Quality Engineer

About the Company: An international life sciences organization operating in a regulated manufacturing environment, focused on delivering high-quality pharmaceutical products through robust quality systems and continuous improvement.

Role Description: As Quality Engineer, you will lead quality investigations and manage deviations, non-conformances, CAPAs and change controls within manufacturing operations. You will work closely with Operations, Engineering, MSAT and QA to identify root causes, maintain GMP compliance and drive effective corrective actions across upstream and downstream processing.

Key Responsibilities: Lead deviation and non-conformance investigations from initiation to closure; Manage CAPAs and change controls, ensuring timely and compliant completion; Perform root cause analysis, including Fishbone Analysis; Review and maintain quality records, procedures and technical documentation; Coordinate with Operations, Engineering, MSAT and QA; Identify risks and implement corrective actions and quality improvements; Support GMP compliance through production floor observations and GEMBA walks; Escalate quality risks and communicate investigation findings to stakeholders.

Requirements: Experience with QMS, deviations, non-conformances, CAPAs and change control; Understanding of manufacturing operations, ideally USP and/or DSP; Strong technical writing and documentation skills; Experience with root cause analysis and investigation management; Experience with COMET, TrackWise or Veeva is an advantage; Pharmaceutical or biotechnology manufacturing experience preferred; food industry experience may also be considered; Strong analytical, organizational and stakeholder management skills; Available to work 2 days per week onsite, with additional onsite presence during onboarding.