Job Description

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