Freelance Production & Process Validation Specialist – Medical Devices📍 Location: Belgium (Antwerp region) | On-site with project-dependent flexibility📅 Contract: 6–12 months | High likelihood of extension⚠️ Freelance / Independent Consultant Only – Senior-level professionals only🚀 The OpportunityWe are partnering with a leading medical device manufacturer in Belgium undergoing regulatory upgrades, MDR transition, and operational process optimisation.We are seeking a Senior Freelance Production & Process Validation Specialist who can step into a regulated, cleanroom-enabled production environment and immediately add value at both operational and strategic levels.This is not a maintenance role, this is for professionals who can structure, elevate, and lead quality and validation processes in medical device manufacturing.🎯 Your ImpactAs a senior authority in production QA and process validation, you will work closely with Production and Quality leadership to ensure compliance with ISO 13485 and MDR regulations.Your responsibilities may include:Operational Quality AssuranceDevelop and maintain production work instructions and SOPs (~150 procedures)Perform batch record reviews and final document checksSupport inspections and audits requiring advanced QA expertiseEnsure accurate and compliant production documentationProcess Documentation & ImprovementMap and analyze production processesIdentify documentation gaps and implement improvementsAlign operational processes with regulatory requirementsProcess ValidationPlan, execute, and document validation activities for production processesSupport validation of new and existing processesEquipment & Maintenance DocumentationTrack equipment and calibration recordsEnsure proper documentation of maintenance and calibration activitiesCross-Functional CollaborationWork with Production Managers for technical process knowledgeAlign with Quality Managers to ensure complianceSupport QA teams in strengthening operational quality✅ Profile RequiredMaster’s degree in Engineering, Biomedical Sciences, Life Sciences, or related fieldExperience in medical device production environmentsStrong knowledge of ISO 13485 (mandatory)Familiarity with MDR regulationsProven freelance/contract experience in QA and process validationHands-on production floor experience, not purely documentation-basedAbility to work autonomously and structure operational processesFluent in English; Dutch or French a plusPharma-only experience is less relevant unless combined with medical devices and MDR exposure💼 What’s OfferedLong-term freelance assignments (6–12 months + possible extension)Competitive daily rates aligned with senior expertiseHigh-visibility roles in regulated, transformation-driven medical device productionDirect collaboration with production and quality leadershipOpportunity to lead, structure, and elevate production QA and process validation systems⚠️ Important: This role is strictly for senior freelance QA professionals with medical device experience. Junior profiles or candidates without contracting experience will not be considered.If you are a senior Production & Process Validation Specialist ready to take ownership in a regulated medical device environment, please send your CV, availability, and daily rate expectations. Only highly relevant profiles will be contacted due to volume.