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
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.
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.
Operational Quality Assurance
Develop and maintain production work instructions and SOPs (~150 procedures)
Support inspections and audits requiring advanced QA expertise
Ensure accurate and compliant production documentation
Map and analyze production processes
Plan, execute, and document validation activities for production processes
Work with Production Managers for technical process knowledge
Align with Quality Managers to ensure compliance
Support QA teams in strengthening operational quality
Master's degree in Engineering, Biomedical Sciences, Life Sciences, or related field
Experience in medical device production environments
Proven freelance/contract experience in QA and process validation
Hands-on production floor experience, not purely documentation-based
Fluent in English; Dutch or French a plus
Pharma-only experience is less relevant unless combined with medical devices and MDR exposure
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.