Quality Engineer | Life Sciences

Capgemini; Diegem; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Free access to learning assets

Mentoring programs

Professional development opportunities

Résumé du poste

Capgemini Engineering, a world leader in engineering services, is seeking a Quality Engineer for the Life Sciences sector to maintain and improve quality systems and ensure regulatory compliance.

You will lead QA activities, perform audits, and collaborate across functions to embed quality throughout the product lifecycle, in Brussels' multilingual environment.

Qualifications

• A minimum of 2 years of experience in quality assurance or quality engineering within Life Sciences.
• Strong knowledge of GMP regulations and quality standards (ISO 13485, FDA 21 CFR, EU GMP, ICH).
• Excellent analytical and problem-solving skills with CAPA, risk management and root cause capabilities.
• Degree in Engineering, Life Sciences, Pharmacy, or related field.
• Proficiency in French and/or Dutch, plus English, for Brussels multilingual environment.

Responsabilités

• Develop, implement and maintain QMS in accordance with GMP and regulatory frameworks.
• Lead QA activities including batch record reviews, product release, change control, deviation management and CAPA.
• Conduct internal and external audits and drive corrective actions to closure.
• Collaborate with manufacturing, regulatory affairs, validation and supply chain to embed quality across the lifecycle.
• Prepare and review quality documentation (SOPs, risk assessments, audit reports, metrics) for regulatory inspections.

Connaissances

Quality Assurance

Regulatory Compliance

GMP/ISO Knowledge

Analytical Thinking

CAPA & Corrective Actions

Root Cause Analysis

Risk Management

English Proficiency

French and/or Dutch

Formation

Engineering, Life Sciences, Pharmacy or related field

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 most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide 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 are the same.Your RoleAs 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 ProfileWe 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 hereOwn 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.