R&d Quality Engineer
Il y a 2 mois
R&D Quality Engineer
**PARIS, FRANCE**
**QUALITY**
**HYBRID**
**FULL-TIME**
- The R&D Quality Engineer position is a key role within the Quality and Regulatory Department of the Medical Business Unit. This position will be part of a cross-functional team that brings our innovative medical device solutions to global markets.What you will do- Represent quality on design and development teams to ensure compliance with internal procedures, global quality management system, and applicable regulatory requirements
- Review, evaluate, and approve HW DHF quality documents (project plans, verification/ validation protocols and reports, I/O matrix, risk charters, etc.)
- Support the design risk charter and identify mitigation strategies to address the identified risks
- Actively work with the R&D team to keep quality documentation, including procedures, work instructions, and templates up to date
- Collaborate on and manage CAPAs and improvement actions for design
- and development-related topics
- Play a central role in liaising with the operational team during the design transfer phase of new or existing products
- Provide general support to process owners and quality managers in their quality management tasks
- Your profile- A minimum of a bachelor’s degree in a technical or related field
- At least 3 years of experience working within a quality, regulatory, or R&D department for medical devices or any other highly regulated industry is preferred
- Excellent verbal and written communication skills in English is required
- Knowledge of relevant medical device standards and regulations (e.g. ISO 13485, 21 CFR820, ISO14971, and EU MDR) is a strong plus
- Good analytical skills; a meticulous approach with a high level of attention to detail
- Passionate about quality assurance and customer satisfaction
- You have strong interpersonal, communication, influencing, and negotiation skills.
- You are outgoing, have a business understanding, and are confident in communicating quality requirements and facilitating effective implementation in a global organization
- You've demonstrated success in delivering results on several technical challenges
- Location and type of contract- Paris, France
- Full-time
- Hybrid
- Associate level
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.
**More information**
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.
- **Personal growth and career advancement**
**Team building**
**Innovation is key**
**Hybrid working & flexibility
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