Quality Engineer | Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Free access to learning platforms

Mentoring programs

Global engineering opportunities

Résumé du poste

Capgemini Engineering, a global leader in engineering services, seeks a Quality Engineer for Life Sciences. You will contribute to Quality Management systems, regulatory compliance, and continuous improvement across pharma and biotech environments.

You will collaborate with cross-functional teams, lead QA/QC activities, and ensure audit readiness for FDA, EMA, and other bodies. Fluency in French/Dutch and English is preferred in Brussels' multilingual setting.

Qualifications

• 2+ years in quality assurance or quality engineering in Life Sciences (pharma/biotech/medical devices).
• Strong knowledge of GMP and ISO 13485, FDA 21 CFR, EU GMP, ICH guidelines.
• Experience with root cause analysis, risk management, CAPA implementation.
• Proactive, detail-oriented, and focused on quality and patient safety.
• Proficiency in French and/or Dutch plus English for Brussels multilingual environment.

Responsabilités

• Develop, implement, and maintain QMS per GMP and regulatory frameworks.
• Lead QA/QC activities: batch review, product release, change control, deviations, CAPA.
• Conduct internal and external audits to ensure regulatory compliance.
• Collaborate with manufacturing, validation, regulatory, and supply chain teams.
• Prepare and review SOPs, risk assessments, audit reports, and quality metrics.

Connaissances

Quality engineering

GMP compliance

Analytical thinking

Problem solving

Multilingual (French/Dutch/English)

Formation

Engineering, Life Sciences, Pharmacy degree

Description du poste

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same.

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.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.