Quality Assurance Engineer

☞ CluePoints - The #1 RBQM Platform for Sponsors & CROs

View: 195

Update day: 26-11-2025

Location: Genval Walloon Brabant Ottignies-Louvain-la-Neuve Louvain-la-Neuve

Category: Quality Assurance / Quality Control R & D Consulting / Customer Service

Industry: Research Biotechnology Chemicals

Position: Associate

Job type: Full-time

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Job content

CluePoints is a fast-growing company and the premier provider of Risk-Based Monitoring and Data Quality Oversight solutions to Bio-Pharmaceutical and Medical Device organizations. Our products utilize advanced statistical algorithms to determine the quality of clinical trial data both during and following study execution. The value of CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing highly efficient site monitoring and a significant reduction in overall regulatory submission risk. CluePoints is seeking outstanding candidates with strong clinical data and analytics skills and a passion for delivery excellence, to help drive customer success and broad adoption of the CluePoints solution.

Responsibilities

As Quality Assurance Engineer, you will be responsible to:

  • Advise on quality requirements and compliance to applicable regulations
  • Ensure quality, completeness and maintenance of the Quality Management System
  • Provide input in validation and qualification activities (including risk analysis and compliance)
  • Manage internal audits/supplier audits and customer audits
  • Handle Deviations
  • Participate in the periodic review process
  • Participate in QMSperformance evaluation

Skills

  • Excellent Englishwritten and verbal communication skills
  • Strong interest inIT environment
  • Good interpersonal skills (communication, organizational and time management skills)
  • Team player, ability to work independently
  • Communicative, assertive, diplomatic and strive for a win-win situation
  • Ability to solve problems and to motivate others
  • Able to utilize pragmatic approach and have an eye for detail
  • Analytical, set priorities quickly, and have the sense of planning and organization

Qualifications

  • Masterin a health or scientific related field, Engineering or equivalent experience
  • Minimum of 1-year experience within a pharmaceutical or regulated environment or equivalent
  • Experience in the clinical research environment is a big plus
  • Experience with Computer System Validation, andregulatory requirements/guidance such as CFR 21, Eudralex, SOC2...)

Top Reasons to Work with Us

  • Work in an ambitious start-up, get a challenging and rewarding job!
  • Work for a fast-growing, multi-disciplinary and international team!
  • On top of that, we offer a competitive salary, company car, fuel card, a Geek & Startup atmosphere, some perks such as: free drinks, cookies, fruits, etc and within a flat hierarchy

Want to work sometimes from homeor work different hours? We can work something out!

We will strictly only consider applications from candidates that are residents and/or hold a valid work permit for the location they apply for.

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Deadline: 10-01-2026

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