Are you looking for a challenging new career?

About FibriCheck

Based in Hasselt, FibriCheck is a dynamic and fast-growing Software as a Medical Device manufacturer in the digital health sector. Our mission is to transform everyday devices into live saving solutions that improve the outcome of cardiovascular diseases.

How? By developing device agnostic heart rhythm disorder detection and prevention solutions that are accessible for everyone, everywhere. FibriCheck is a Software as a Medical Device – cleared or approved to be marketed in different geographies including Europe and the United States. FibriCheck has been used today by over 1 million people, is prescribed by over 2.500 physicians and has processed over 20 million PPG measurements.

To strengthen our team, we are looking for a Quality Engineer.

About the role

As a Quality Engineer, you will be a pivotal member of the Quality and Regulatory Affairs team, reporting to the Quality and Regulatory Affairs Manager. You will contribute to the effective implementation and maintenance of the ISO 13485 Quality Management System in accordance with applicable regulatory requirements and internal processes of the company.

This role focuses primarily on quality, allowing our regulatory specialists to focus on market access and compliance. You oversee development activities affecting all parts of the lifecycle of the medical device. You monitor the non-conformance system, change management system and CAPA system. You contribute to promoting the Quality mindset and facilitate transversal communication within teams.

Key responsibilities

• Maintain and improve the QMS to ensure compliance with ISO 13485 and other applicable standards. Work closely with Regulatory Affairs to align quality activities with market-specific regulatory requirements.
• Prepare for and participate in external and internal audits, ensuring readiness and effective follow-up on findings.
• Support the development of processes for SaMD lifecycle management, including risk management, usability engineering, and product realisation.
• Ensure supplier compliance to QMS, regulatory and process requirements through supplier monitoring and supplier audits.
• Handle non-conformities and complaints through executing root cause investigations and applying Corrective and Preventive Actions where needed.
• Collaborate on defining and monitoring quality-related key performance indicators (KPIs)
• Collaborate closely with cross-functional teams to implement quality processes, provide training and guidance and quality requirements, foster a culture of quality within the company and drive continuous improvement.

Qualifications and skills

• A Master’s or a Bachelor’s degree in an engineering, technical or scientific discipline or equivalent through experiences.
• A minimum of 3 years of work experience in a medical device quality function, experience in quality management for Software as a Medical Device is an asset.
• In depth knowledge of Quality Management System requirements according to ISO 13485 and their application in software development.
• Familiarity with regulatory requirements for medical devices in the EU and US markets.
• Process-oriented and solution-driven.
• Excellent interpersonal, communication, writing and presentation skills.
• High level of attention to detail, excellent organisational skills and time management.
• Fluent in English, written and spoken.

Why join us?

• Opportunity to make a meaningful impact on revolutionising healthcare 
• Flexible work and high degree of self-management
• Very open and transparent company culture
• Ability to work remotely and/or in our office in Hasselt
• Great colleagues and a fun environment (team buildings, afterwork drinks,…)
• Competitive salary package with various extra-legal benefits (company car, fuel card, meal vouchers, insurances,…)

How to apply?

The application procedure looks like this:

1. You send your CV and motivation letter to us. You can expect a reply within 10 business days.
2. Are we both excited? Then we will follow up with a virtual introduction meeting with our Quality & Regulatory team lead to discuss your application.
3. If we’re still both excited we’ll organize a final meeting with the Quality & Regulatory team lead and our CEO.
4. Do we have a match? Then you will receive a proposal to join our team!

If you are interested please send your CV and motivation to  qm@fibricheck.odoo.com. By sending us your application, you consent to our Privacy Policy for applicants.