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 Opportunity
We 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 Impact
As 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 Assurance
* Develop and maintain production work instructions and SOPs (~150 procedures)
* Perform batch record reviews and final document checks
* Support inspections and audits requiring advanced QA expertise
* Ensure accurate and compliant production documentation
Process Documentation & Improvement
* Map and analyze production processes
* Identify documentation gaps and implement improvements
* Align operational processes with regulatory requirements
Process Validation
* Plan, execute, and document validation activities for production processes
* Support validation of new and existing processes
Equipment & Maintenance Documentation
* Track equipment and calibration records
* Ensure proper documentation of maintenance and calibration activities
Cross-Functional Collaboration
* Work with Production Managers for technical process knowledge
* Align with Quality Managers to ensure compliance
* Support QA teams in strengthening operational quality
✅ Profile Required
* Master’s degree in Engineering, Biomedical Sciences, Life Sciences, or related field
* Experience in medical device production environments
* Strong knowledge of ISO 13485 (mandatory)
* Familiarity with MDR regulations
* Proven freelance/contract experience in QA and process validation
* Hands-on production floor experience, not purely documentation-based
* Ability to work autonomously and structure operational processes
* Fluent in English; Dutch or French a plus
* Pharma-only experience is less relevant unless combined with medical devices and MDR exposure
💼 What’s Offered
* Long-term freelance assignments (6–12 months + possible extension)
* Competitive daily rates aligned with senior expertise
* High-visibility roles in regulated, transformation-driven medical device production
* Direct collaboration with production and quality leadership
* Opportunity 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.