Quality engineer

• Quality Assurance
• Netherlands, Leiden
• 29 juni 2026
• Fulltime
• hbo
• V-193294
• €70 per annum

Quality Engineer

Job Summary
As a Quality Engineer (Investigation Owner), you are responsible for leading quality investigations related to manufacturing processes, products, and quality systems. You will identify root causes of quality issues, drive corrective and preventive actions (CAPAs), and ensure compliance with GMP, internal quality standards, and regulatory requirements. Working closely with cross-functional teams, you will contribute to continuous improvement initiatives and help maintain the highest standards of product quality and patient safety.

Key Responsibilities

• Lead non-conformance investigations from initiation through closure.
• Own and manage CAPA records and Change Controls (CC) for the Operations Unit.
• Perform root cause analyses and define effective corrective and preventive actions.
• Review and approve documentation related to manufacturing processes and operational activities.
• Ensure quality records are accurate, compliant, and completed within required timelines.
• Maintain and update procedures and quality documentation based on regulatory changes, audits, and internal investigations.
• Identify, assess, and escalate quality and compliance risks where appropriate.
• Initiate and support risk mitigation activities and continuous quality improvement projects.
• Conduct regular GMP GEMBA walks to verify compliance on the production floor, identify improvement opportunities, and collaborate with stakeholders to implement corrective actions.

Qualifications

• Bachelor’s degree (HBO or equivalent) in a relevant field.
• Minimum of 5 years of experience in a Quality Engineer, Investigation Lead, or similar role within the pharmaceutical industry.
• Solid knowledge of GMP, quality investigations, CAPA, and Change Control processes.
• English language proficiency at B2 level or higher.
• Proficient in Microsoft Office and experienced with quality management systems and data analysis.

Competencies
We are looking for a proactive and quality-focused professional who:

• Demonstrates strong analytical and problem-solving skills.
• Takes ownership and is accountable for delivering results.
• Works accurately, independently, and effectively under pressure.
• Is well-organized and able to manage changing priorities.
• Communicates effectively with cross-functional teams and stakeholders.
• Builds strong working relationships and contributes to a culture of continuous improvement.