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

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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.

What we offer

Work culture

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