Senior QA Engineer – Medical Devices (EU)

Merit Medical Systems, Inc.; Maastricht; On-site; EUR 55,000 - 85,000; Full time

Job summary

Merit Maastricht (The Netherlands) serves as the European Headquarters and Distribution Center of Excellence. The Quality Engineer will support the European QMS, ensuring compliant distribution, storage, and product release of medical devices.

You will lead CAPA, audits, and change control to uphold regulatory obligations across the region. This role requires a strong background in ISO 13485, EU MDR distributor requirements, and post-market quality processes, with emphasis on collaboration with

Qualifications

• Bachelor’s degree in a technical field.
• ≥5 years of experience in Quality, Manufacturing, Distribution, Regulatory, or Supply Chain within a regulated industry.
• Working knowledge of ISO 13485 and EU MDR distributor requirements.
• Experience supporting warehouse, distribution, logistics, product release, traceability, or post‑market quality processes.
• Strong written and verbal communication in English; Dutch preferred.
• Proficiency with electronic QMS, ERP, WMS, Microsoft Office, and data analysis tools.

Responsibilities

• Support day-to-day quality oversight of receiving, inspection, storage, picking, packing, shipping, returns, quarantine, and product release activities within the distribution centre.
• Verify that distributed medical devices meet applicable requirements before release, including CE marking, product labelling, instructions for use, UDI, importer information where applicable, and required documentation.
• Ensure storage and transportation conditions remain aligned with manufacturer requirements, including temperature, humidity, segregation, cleanliness, and protection from contamination or damage.
• Manage or support nonconformance investigations, deviations, product holds, quarantine decisions, and disposition activities in collaboration with Operations, Regulatory Affairs, Supply Chain, and Quality leadership.
• Support complaint intake, escalation, investigation coordination, trend review, and communication with manufacturers or responsible economic operators as required.
• Initiate, investigate, and follow up on corrective and preventive actions, including root cause analysis, effectiveness checks, and timely closure.
• Perform process monitoring, quality data analysis, and trend reporting for distribution-related quality indicators.
• Support internal audits, external audits, notified body audits, competent authority inspections, and customer audits by preparing records, responding to findings, and driving remediation actions.
• Maintain and improve local quality procedures, work instructions, forms, training materials, and quality records.
• Participate in change control, risk assessment, validation, equipment qualification, calibration, and process improvement activities impacting distribution quality.
• Promote a quality and compliance culture by providing coaching, training, and technical guidance to warehouse and distribution personnel.
• Performs other related duties and tasks as required.

Skills

Quality management

Regulatory affairs

Documentation control

Data analysis

English proficiency

Dutch preferred

Education

Bachelor’s degree

Tools

ERP system

QMS software

WMS

Microsoft Office

Job description

Merit Maastricht (The Netherlands) serves as the European Headquarters and Distribution Center of Excellence. The Quality Engineer will support the European QMS, ensuring compliant distribution, storage, and product release of medical devices.

You will lead CAPA, audits, and change control to uphold regulatory obligations across the region. This role requires a strong background in ISO 13485, EU MDR distributor requirements, and post-market quality processes, with emphasis on collaboration with