CQA Specialist - Benelux (Medical Devices)

Location: Braine-l'Alleud, Belgium

Company

hirify.global develops vital organ therapy solutions, including kidney care technologies, digital solutions, and advanced services for patients and care teams.

What you will do

• Maintain relevant regulatory licenses, including WDA and MIA.
• Ensure outsourced storage and distribution activities comply with European and local legal requirements.
• Implement and maintain Corporate Quality Systems across Benelux entities, including ISO 9001 and ISO 13485 certifications.
• Act as the Post Market Surveillance and local contact person for medical devices.
• Provide quality support for local business initiatives and maintain contacts with Regulatory Affairs, Pharmacovigilance, 3PL providers, transporters, and business functions.
• Serve as a backup Responsible Person.

Requirements

• Master's degree in Pharmaceutical Sciences, Medicine, Chemistry, Biology, Biomedical Sciences, or Bioengineering; eligibility as a Responsible Person is required.
• Prior experience in quality or an equivalent role within a pharmaceutical or medical device company, CRO, or similar organization is preferred.
• Fluency in Dutch or French, working proficiency in the other national language, and working proficiency in English are required.
• Knowledge of GDP and GMP standards, applicable quality systems, medical industry processes, and product and process validation methodology.
• Functional knowledge of ERP and data management systems, plus basic office software skills.
• Strong interpersonal, communication, organizational, and project management skills, with the ability to collaborate with multicultural teams.

Nice to have

• Knowledge of TrackWise, JDE, or other ERP systems.
• Knowledge of ISO certification processes.

Culture & Benefits

• Collaborative work with internal and external stakeholders while also supporting independent ownership.
• Opportunities to develop new ways of working as the organization evolves.
• Reasonable accommodations are available during the application and interview process.