Job Opportunity: Quality Engineer – Life Sciences
Location: 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