Freelance Production & Process Validation Specialist – Medical Devices
Location: Belgium (Antwerp region) | On-site with project-dependent flexibilityContract: 6–12 months | High likelihood of extensionFreelance / 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 documentation
Process Documentation & ImprovementMap and analyze production processesIdentify documentation gaps and implement improvementsAlign operational processes with regulatory requirements
Process ValidationPlan, execute, and document validation activities for production processesSupport validation of new and existing processes
Equipment & Maintenance DocumentationTrack equipment and calibration recordsEnsure proper documentation of maintenance and calibration activities
Cross-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.