Devices development and LCM Quality lead
Are you passionate about medical device quality and innovation? Do you thrive in an environment where precision, collaboration, and continuous improvement matter? We’re looking for a Device Quality Lead based in Belgium to join our dynamic, international team.
This is more than a job—it’s a mission-critical role that supports the development and quality management of combination medical devices, including cutting-edge technologies like auto-injectors and pen injectors.
Why This Role Is Perfect for You
Remote-friendly: Enjoy flexible remote work from Belgium, while staying connected with a collaborative European team.
Impactful Work: Lead initiatives that directly improve patient safety and product quality.
Travel Opportunities: Occasional travel across Europe to visit suppliers and engage in high-impact quality audits and reviews.
What You’ll Be Doing
Supporting the development and design control of medical devices aligned with ISO 13485, ISO 14971, and ISO 11608.
Managing supplier quality, ensuring full compliance with internal design control procedures.
Leading risk management processes and addressing non-conformities during development and clinical phases.
Supporting commercial operations, including product testing and material change reviews.
Ensuring regulatory compliance and harmonisation during solution integration.
Contributing to document reviews, maintaining the design history file and other key quality documentation.
Driving process improvements to enhance efficiency and quality.
Must-Have Skills
Proven expertise in medical device development and quality management.
Deep knowledge of ISO 13485, ISO 14971, and ISO 11608.
Strong background in supplier management and design control.
Sharp risk management acumen.
Fluent English communication skills (written and spoken).
Ability to think beyond compliance—technically sharp and improvement-driven.
Familiarity with regulated environments (e.g., ISO 9001).
Nice-to-Have Skills
Knowledge of both US and EU regulations.
Experience with auto-injectors, pen injectors, and combination products.
Comfort proposing and implementing process improvements.
French proficiency is a plus (especially for regional collaboration).
Background in pharmaceutical/biopharmaceutical sectors.
Knowledge of supply chain or audit management.
Experience with primary packaging and containers.
Interview Process
You’ll first meet with our team leads Marco and Kevin to discuss your experience and mindset. Then, a follow-up session with stakeholders will help align expectations and ensure the best fit for both sides.
Ready to Apply?
If you value teamwork, continuous learning, and making a difference in healthcare, this opportunity could be your perfect fit. Apply now and be part of a company that cares deeply about quality, innovation, and people.
