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Quality engineer

Bruxelles
Vivid Resourcing
Publiée le 4 septembre
Description de l'offre

Job Opportunity: Quality Engineer – Life SciencesLocation: Brussels Employment type: On-site Department: Quality Assurance & Compliance About Us:We are a growing organization within the Life Sciences sector, dedicated to advancing healthcare through innovation, precision, and excellence. Our team works at the forefront of (pharmaceuticals / biotechnology / medical devices / diagnostics), ensuring safe, effective, and compliant products reach patients worldwide. Role Overview:As a Quality Engineer, you will play a key role in maintaining and improving our quality management systems (QMS) while driving compliance with GMP, ISO, and regulatory requirements (FDA/EMA). You will collaborate with cross-functional teams in production, R&D, and supply chain to ensure product quality, process reliability, and continuous improvement. Key Responsibilities:Ensure compliance with ISO 13485 / ISO 9001 / GMP / ICH guidelines and regulatory standards.Perform risk assessments, CAPA investigations, and root cause analyses (e.g., 5 Whys, Fishbone, FMEA).Lead and support internal and supplier audits; contribute to regulatory inspections.Develop, review, and maintain SOPs, validation protocols (IQ, OQ, PQ), and quality documentation.Support equipment qualification, process validation, and test method validation.Conduct statistical analysis (SPC, Cp/Cpk, DOE) to monitor and improve product quality.Collaborate with production teams to ensure deviation management, change control, and batch record review.Drive continuous improvement initiatives using Lean and Six Sigma principles. What We’re Looking For:Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.2–5 years’ experience in Quality Assurance / Quality Engineering within pharma, biotech, or medical devices.Strong knowledge of GMP, ISO 13485, FDA 21 CFR Part 11, and EMA guidelines.Analytical skills with experience using Minitab, JMP, or similar statistical tools.Excellent communication and problem-solving skills; able to work cross-functionally.Auditing experience (internal or external) is a strong plus.Certifications such as Lean Six Sigma Green Belt or ASQ Certified Quality Engineer (CQE) are advantageous. What We Offer:A dynamic and innovative environment in the Life Sciences industry.Opportunities for professional development, training, and certification.Competitive salary package with benefits (bonus, meal vouchers, group insurance, etc.).A culture of collaboration, innovation, and continuous learning.Salary: Up to €7,000 (Dependant on Experience) If this role is of interest, contact me on LinkedIn or below:Trishan.Patel@vividresourcing.com

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