Engineer, Quality Assurance CAPA III

About the role

The Quality Assurance CAPA Engineer will manage the resolution of exception reports (NCRs, PRAs) and audit findings, ensuring that investigations, corrective actions, and preventive measures are documented and implemented in compliance with GMP and corporate regulations.

Key responsibilities

• Review and approve documentation generated from exception reports, capturing containment, correction, and prevention actions.
• Act as a subject‑matter expert in cross‑functional working sessions to develop investigations and define CAPA plans.
• Guide the NCR and audit processes to meet internal and regulatory requirements.
• Prioritize resources for timely execution of CAPA activities and provide status updates.
• Explain exception documentation during internal and external audits.
• Ensure compliance with corporate and legal EHS policies and drive continuous improvement of EHS performance.
• Continuously improve quality system processes through simplification and optimization.
• Perform other duties as assigned by the supervisor.

Required profile

• Bachelor’s degree in Engineering (preferably electromechanical, electrical, or chemistry).
• Minimum of 3 years of experience in quality assurance, CAPA, or related fields.
• Intermediate English proficiency (B2+), C1 preferred.

Required skills

• Good Manufacturing Practices (GMP) knowledge.
• CAPA and root‑cause analysis methodology.
• NCR and audit management.
• EHS compliance and reporting.