Quality Assurance Engineer III

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

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

SUMMARY OF DUTIES

The Quality Engineer is responsible for supporting and maintaining the Quality Management System within a European medical device distribution centre. This role ensures that distribution, storage, handling, product release, nonconformance, complaint escalation, CAPA, and quality improvement activities are performed in compliance with applicable regulatory requirements, company procedures, ISO 13485 expectations, EU MDR distributor obligations, and customer requirements.

DUTIES & 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.

SUMMARY OF MINIMUM QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Supply Chain, or a related technical discipline.
• Minimum 5 years of experience in Quality, Manufacturing, Distribution, Regulatory, or Supply Chain within the medical device, pharmaceutical, life sciences, or other regulated industry.
• Working knowledge of ISO 13485, EU MDR requirements for distributors, nonconformance management, CAPA, complaint handling, and audit readiness.
• Experience supporting warehouse, distribution, logistics, product release, traceability, or post‑market quality processes.
• Strong written and verbal communication skills in English; additional Dutch is preferred.
• Proficiency with electronic QMS, ERP, warehouse management systems, Microsoft Office, and data analysis tools.

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with an international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide.

Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses. More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.