Quality Engineer

Sire Search; Leiden; On-site; EUR 70,000 - 90,000; Full time

Job summary

Sire Search in the Netherlands is seeking a Quality Engineer (Investigation Owner) to lead and manage quality investigations across manufacturing processes, products, and systems. You will identify root causes, drive CAPA actions, and ensure regulatory and internal standards are met.

The role requires collaboration with cross-functional teams, documentation of findings, and implementation of process improvements. Strong analytical thinking and stakeholder communication are essential.

Qualifications

• HBO degree with relevant quality investigations experience in pharma.
• Proven ability to lead root cause investigations and CAPA.
• Strong documentation and data-analysis skills.

Responsibilities

• Lead root cause investigations of non-conformances and quality issues, including managing CAPA records and change controls from initiation to completion.
• Review and support documentation associated with manufacturing processes and activities.
• Maintain and update procedures and quality records, ensuring compliance with regulatory requirements.
• Initiate and support risk mitigation initiatives and continuous quality improvement projects.
• Support formal escalation processes related to safety, product quality, and regulatory compliance risks.
• Conduct GEMBA walks regularly to observe GMP adherence, identify areas for improvement, and implement corrective actions.
• Assemble and lead teams for quality record management, escalating issues as needed, and maintaining high professional standards.

Skills

Root cause analysis

CAPA management

Change controls

Regulatory compliance

Documentation

GEMBA walks

Quality records

Stakeholder communication

Analytical thinking

Prioritization

Education

HBO degree

Tools

MS Office

Data analysis tools

Job description

Company overview

Our client is a leading pharmaceutical company committed to delivering high-quality products through innovative processes and rigorous standards. They focus on continuous improvement and patient safety, maintaining excellence across all facets of their operations.

Job description

We are seeking a skilled Quality Engineer (Investigation Owner) to lead and manage quality investigations related to manufacturing processes, products, and systems. The ideal candidate will be responsible for identifying root causes of quality issues, driving corrective and preventive actions, and ensuring compliance with regulatory and internal standards. This role requires close collaboration with cross-functional teams to document findings, implement process improvements, and communicate effectively with stakeholders.

Responsibilities

• Lead root cause investigations of non-conformances and quality issues, including managing CAPA records and change controls from initiation to completion.
• Review and support documentation associated with manufacturing processes and activities.
• Maintain and update procedures and quality records, ensuring compliance with regulatory requirements.
• Initiate and support risk mitigation initiatives and continuous quality improvement projects.
• Support formal escalation processes related to safety, product quality, and regulatory compliance risks.
• Conduct GEMBA walks regularly to observe GMP adherence, identify areas for improvement, and implement corrective actions.
• Assemble and lead teams for quality record management, escalating issues as needed, and maintaining high professional standards.

Requirements

• HBO degree with a minimum of 5 years of experience as a Lead Investigator, Quality Engineer, or in a similar role within the pharmaceutical industry.
• Proficiency in English at B2 level.
• Intermediate proficiency in MS Office, routine data analysis skills, and familiarity with business applications at a specialist level.
• Proactive, organized, decisive, and able to work independently or in a team environment.
• Stress-resistant with the ability to remain calm under pressure.
• High accuracy, attention to detail, and a quality-oriented approach.
• Adaptable to changing priorities and proactive in addressing issues.
• Strong analytical thinking skills to deal with complexity, ask questions, analyze data, identify root causes, and develop innovative solutions.
• Effective at prioritizing tasks to meet deadlines and ensure timely results.
• Excellent stakeholder communication skills and ability to build strong relationships.

Other Information

This position is based in the Netherlands and offers an opportunity to work in a dynamic, regulated environment within the pharmaceutical sector. The role is ideal for candidates with a strong investigative mindset and a passion for maintaining high-quality standards.