R&D Quality Engineer
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
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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.