Quality Engineer

DPS Group Global; Leiden; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

DPS Group Global is looking for a Quality Engineer (Investigation Owner) in Leiden to lead quality investigations, drive root cause analysis, and manage CAPA activities within a GMP-regulated pharmaceutical setting.

You will work with cross-functional teams, ensuring compliant documentation and effective corrective actions, while contributing to continuous improvement on the production floor.

Qualifications

• HBO degree in science or engineering with relevant background.
• Minimum 5 years in Quality Engineering, Investigation Lead or GMP-regulated role.
• Pharmaceutical or biotech experience is essential.
• Fluency in English (B2 or higher).
• Strong knowledge of deviation investigations, CAPA, and Change Control.

Responsabilités

• Lead non-conformance investigations from initiation through closure.
• Own and manage CAPA records and Change Controls (CC).
• Perform root cause analysis and implement effective corrective and preventive actions.
• Review and maintain quality documentation for manufacturing operations.
• Ensure timely and compliant completion of quality records.
• Support quality improvement initiatives and risk mitigation activities.
• Participate in formal escalation processes related to product quality, safety, and compliance.
• Conduct regular GEMBA walks on the production floor to monitor GMP adherence and identify improvement opportunities.
• Collaborate with cross-functional teams and communicate investigation outcomes to key stakeholders.

Connaissances

Analytical skills

Root cause analysis

Stakeholder management

Communication

Problem-solving

Formation

HBO degree in science/engineering

Outils

CAPA

Change Control

GEMBA walks

Description du poste

Quality Engineer (Investigation Owner) | Leiden, Netherlands | 12-Month Contract

We are currently looking for an experienced Quality Engineer (Investigation Owner) to join a leading international pharmaceutical organization in the Leiden area.

In this role, you will be responsible for leading quality investigations, driving root cause analysis, managing CAPA activities, and ensuring compliance with GMP and regulatory requirements. You will work closely with cross-functional stakeholders to maintain the highest quality standards while supporting continuous improvement initiatives within a manufacturing environment.

Key Responsibilities

• Lead non-conformance investigations from initiation through closure
• Own and manage CAPA records and Change Controls (CC)
• Perform root cause analysis and implement effective corrective and preventive actions
• Review and maintain quality documentation for manufacturing operations
• Ensure timely and compliant completion of quality records
• Support quality improvement initiatives and risk mitigation activities
• Participate in formal escalation processes related to product quality, safety, and compliance
• Conduct regular GEMBA walks on the production floor to monitor GMP adherence and identify improvement opportunities
• Collaborate with cross-functional teams and communicate investigation outcomes to key stakeholders

What We’re Looking For

• HBO degree or equivalent in a relevant scientific or engineering discipline
• Minimum 5 years of experience in a Quality Engineering, Investigation Lead, or similar GMP-regulated role
• Pharmaceutical or biotech industry experience is essential
• Strong knowledge of deviation investigations, CAPA, and Change Control processes
• Experience working within GMP-regulated manufacturing environments
• Strong analytical and problem-solving skills with the ability to identify root causes and develop sustainable solutions
• Ability to manage multiple priorities and work effectively in a fast-paced environment
• Professional communication skills and stakeholder management experience
• Fluency in English (minimum B2 level)

Industry: Global Pharmaceutical Manufacturing