Senior Medical Quality Engineer - #49540

LEUVEN, BELGIUM

PARIS, FRANCE

QUALITY

HYBRID

FULL-TIME

ENGLISH CV

Are you passionate about quality in medical manufacturing and driven by patient safety? Do you enjoy working closely with engineering teams and suppliers to ensure compliant, efficient, high-quality production processes? Join our Medical Quality team to help improve the quality of cranio-maxillofacial and orthopaedic medical devices

Job description

As a Senior Quality Engineer, you are a key expert within the Medical Quality team, supporting both internal and external manufacturing processes for our cranio-maxillofacial and orthopaedic portfolio. You'll help ensure that manufacturing activities for medical devices comply with quality system and regulatory requirements while supporting continuous improvement across processes and suppliers. You'll be part of the Quality Team within the Medical Business Unit and report directly to the Medical Quality Manager at our headquarters in Leuven, Belgium. In this role, you will collaborate closely with quality and engineering colleagues across our global organization, including teams in France and the US What you will do

• Provide daily QA support for internal manufacturing-related processes for medical devices, including contract manufacturing, manufacturing, warehousing, incoming goods inspection, packaging, and assembly
• Review and approve non-conformities, deviations, quality events, and monitoring reports
• Advise and support process engineering teams in the setup of new production processes and changes to existing ones
• Ensure that quality system and regulatory requirements are respected from scoping through implementation
• Review and approve changes related to manufacturing procedures, manufacturing processes, risk management, and validation activities
• Drive improvements and corrective actions by managing CAPAs
• Perform root cause analyses of quality issues and define, execute, and follow up action plans until effectiveness is demonstrated
• Participate in internal projects involving suppliers to ensure established Supplier Quality Assurance processes are followed
• Evaluate and approve new suppliers for medical manufacturing activities
• Conduct yearly re-evaluations of existing suppliers
• Coordinate with suppliers on quality plans to assess, investigate, and define action plans for identified or potential issues
• Perform supplier audits and follow up on the resolution of non-conformities
• Participate in external audits at Materialise by notified bodies, regulatory agencies, competent authorities, and customers
• Contribute to other Quality Department activities, including internal audits

Your profile

• Master’s degree in science or engineering, or equivalent through relevant professional experience in quality management
• At least 3 years, preferably 5 years, of relevant experience in quality, manufacturing, or engineering within the medical device industry
• Good knowledge of ISO 13485:2016; knowledge of 21 CFR 820 and EU MDR is a strong plus
• Passion for quality and continuous improvement, with a strong focus on patient safety and customer satisfaction
• Strong communication skills and the ability to build constructive relationships with internal stakeholders
• Able to promote and maintain a strong quality mindset across teams
• Proactive and eager to take initiative when identifying issues or opportunities for improvement
• Well organized, pragmatic, hands-on, and flexible in your way of working
• Able to keep the bigger picture in mind and define phased improvement approaches
• Willing to travel frequently between the Leuven and Paris Materialise offices
• Fluent in English and French, both spoken and written

What we offer

Healthy life-work balance When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony Hybrid working & flexibility Personal growth and career advancement Team building Innovation is key Location and type of contract

• Leuven, Belgium or Paris, France
• Full-time
• Hybrid
• Mid-senior level
• CV in English

Working at Materialise

Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work