Complaint and Post-Market Surveillance Specialist

Spreek je Nederlands en heb je ervaring in Quality Assurance binnen de Medical Device industrie? Dan horen we graag van je.

An international Medical Device company is currently looking for a Complaint & PMS Specialist to join its Quality team in the Utrecht area.

You will be part of a team of three people, reporting to the QA Manager, and will play a key role in maintaining and executing the Complaint Handling and Post-Market Surveillance (PMS) processes, ensuring compliance with ISO 13485, MDR/MDD and international regulatory requirements.

In this position, you will contribute to monitoring product performance after market release and support continuous improvement initiatives throughout the product lifecycle.

This role is particularly suited to an early-career Quality professional within the Medical Device industry, who is comfortable managing complaint investigations and working within a regulated environment.

Key Responsibilities :

• Manage and investigate customer complaints while collecting and analysing PMS data to monitor product performance after market release.
• Ensure complaint and PMS activities comply with ISO 13485, MDR/MDD and internal quality procedures, while supporting regulatory reporting and audits.
• Identify non-conformities, initiate and follow up Corrective and Preventive Actions (CAPA), and verify the effectiveness of implemented actions.
• Contribute to product risk management by integrating complaint and PMS findings into risk files and supporting cross-functional risk reviews.
• Act as a key point of contact for complaint and PMS topics, working closely with teams such as Production, R&D and Customer Service.

 Profile :

• Previous experience in QA, Complaint Handling or PMS within Medical Device or Pharmaceutical manufacturing
• Good knowledge of ISO 13485, MDD and MDR regulatory frameworks
• Fluent in English and Dutch

 Salary & Benefits :

• Up to 55k€ per annum according to profile & experience
• Annual bonus depending on company's results
• Work From Home policy : 2 days per week maximum (manager approval)
• Transportation allowance
• Pension scheme Defined Benefit Plan until 2028 (transition to Defined Contribution Plan)

Send your CV to t.perriaux@eurolondon.com

Only shortlisted candidates will be contacted

#MedicalDevices #QualityAssurance #UtrechtJobs