About the company
As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 38,000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical EMEA, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.
We are looking for a Quality Assurance Specialist who is detail-oriented, proactive, and collaborative to join us in our Quality team, based in our Mechelen office in Belgium.
About the role
You will be working in a team that ensures our products and processes meet the highest quality standards. As a Quality Assurance Specialist, you will play a key role in managing complaints, supporting vigilance activities, and maintaining our Quality Management System in compliance with ISO 13485:2016 and relevant regulations.
What you’ll do
Complaint handling (40%)
- Manage and monitor product complaints and ensure timely resolution
- Act as liaison between technical teams and legal manufacturers
- Master and improve the IT tools used in complaint handling.
- Effectively manage the goods return and quarantine procedures in closed collaboration with Operations team
Vigilance activities (10%)
- Lead vigilance activities and ensure regulatory timelines are met
- Proactive request reportability to the legal manufacturers
- Draft Manufacturer Incident Reports and submission to the health authorities respecting MDR timelines.
- Leading or supporting FSCA and recall when needed, upon QA Manager request.
Quality Management System (35%)
- Maintain and improve quality documentation and reporting in accordance to MDR regulations and ISO 13485:2016
- Support the QA Manager in preparing reporting and management review reports
Internal and External Audits (15%)
- Support internal and external audits and follow up on findings
- Ensure CAPA documentation and follow up
What you’ll need
- Bachelor’s degree in a scientific or technical field
- Experience with ISO 13485:2016 and medical device regulations
- Strong analytical and problem-solving skills
- Excellent communication and coordination abilities
- Proficiency in quality systems and complaint handling tools
- Ability to work independently and collaboratively in a team
Why you should apply
You will be working in the Europe Middle East and Africa HQ of a leading organization of the medical device sector
In this HQ we have more than 30 different nationalities, making our environment very multicultural
We offer home working possibilities: 2 days per week
You will be joining a purpose-driven organization where quality and patient safety are at the heart of everything we do.
In this role, you’ll have the opportunity to make a real impact, work with a supportive and experienced team, and grow your expertise in a regulated and dynamic environment.
NIPRO delivers on its purpose to help all people Live Longer. Live Better.
Our purpose is grounded in care, respect, and a deep commitment to the well-being of every life we touch—patients, partners, and team members.. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world-class healthcare accessible to all.
Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together.