Quality Engineer - Life Sciences

Your Role

As a Quality Engineer in the Life Sciences sector, you will play a key role in maintaining and improving quality systems, ensuring regulatory compliance, and supporting continuous improvement initiatives across pharmaceutical and biotech environments. In this role you will play a key role in:

• Developing, implementing, and maintaining quality management systems (QMS) in accordance with GMP guidelines and relevant regulatory frameworks such as ISO 13485, FDA 21 CFR, and EU GMP, ensuring full compliance across all quality processes.
• Leading and supporting quality assurance and quality control activities, including batch record reviews, product release, change control, deviation management, and CAPA processes to ensure consistent product quality.
• Conducting internal and external audits to assess compliance with regulatory requirements and company quality standards, identifying areas for improvement and driving corrective actions to closure.
• Collaborating with cross-functional teams including manufacturing, validation, regulatory affairs, and supply chain to embed a culture of quality and ensure seamless integration of quality requirements throughout the product lifecycle.
• Preparing and reviewing quality documentation such as SOPs, risk assessments, audit reports, and quality metrics, ensuring all documentation is accurate, up-to-date, and audit-ready for regulatory inspections by bodies such as the FDA, EMA, and FAMHP.

Your Profile

We are looking for a quality-focused and detail-oriented professional who thrives in a regulated environment. You will bring:

• A minimum of 2 years of experience in quality assurance or quality engineering within the Life Sciences industry, including pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of GMP regulations and quality standards such as ISO 13485, FDA 21 CFR, EU GMP, and ICH guidelines, with a proven ability to apply these in a practical, project-based environment.
• Excellent analytical and problem-solving skills, with experience in root cause analysis, risk management, and CAPA implementation, and the ability to drive quality improvements across complex, regulated environments.
• A degree in Engineering, Life Sciences, Pharmacy, or a related field, combined with a proactive mindset, exceptional attention to detail, and a strong commitment to quality and patient safety.
• Proficiency in French and/or Dutch, as well as English, enabling effective communication in Brussels' multilingual professional environment.

What you'll love about working here

• Own your Growth: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more. Our engineering academy offers more than 60,000 hours of training to support your professional development.

• Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.

• Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.