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Senior Medical Quality Engineer

Materialise -
Louvain

Soumettre votre candidature

Détails de l'emploi

Temps plein
Il y a 4 jours

Avantages

Salle de sport sur place
Événements d'entreprise

Qualifications

Français
Anglais
Master
Production
Compétences en communication

Description complète du poste

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.

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