Quality Engineer

A super-hero working for the compliance of medical devicesISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 mean more than a series of numbers and letters for you? Working on several projects in parallel does not scare you? But, on the contrary, you are looking for a varied job? Knowing that your job can have an impact on people's health gets you motivated to wake up every morning?Then read below:Who we are?COVARTIM is an engineering company. Our mission is to help the MedTech industry foster medical innovation and improve health care.More concretely, we support any kind of organisation (practitioners, startups, SMEs, big companies) in the development and the certification of their medical technologies.In a nutshell:A (small) team of 20 people (24-52 years old) always ready to help each other (and play table football);40+ projects in parallel every month;150+ clients in BeNeLux, France, USA, Japan, Finland, …In order to answer the constantly growing demand from current and future clients, we are looking for Quality Engineers for our office in La Rochelle (France).The job is open-ended, to be filled immediately.Practically, what will you do?Your mission will be to:Implement Quality Management Systems at our clients, based on the one we have developed;Perform internal and external audits at our clients;Develop regulatory strategies for the introduction of innovative medical devices on the market;Review and prepare documentation for Notified Bodies, FDA, and the competent authorities;Provide our clients with operational support (hands-on);Perform regulatory watch and gap analysis to make sure we are still best-in-class.How?We perform projects for our clients in our office in La Rochelle. Sometimes we go to our clients' premises for kick-off and follow-up meetings and for audits. Some clients want to see us once a week, others are located thousands of km from our office and only see us on Teams. This means that we spend most of our time at the office, together with the team.What about the team?Our members are gathered in two teams: the Product Development team and the Quality Assurance & Regulatory Affairs (QA/RA) team. As a Quality Engineer, you will join the QA/RA team.The mission of the QA/RA team is to help our clients achieve the compliance of their devices with regards to the regulatory framework and to provide support for the introduction on the market.Examples of projects:Development of the US regulatory strategy for a software (Class IIa);Support to solve non-conformities after an audit on biocompatibility and packaging and to achieve CE mark for orthopaedic implant and instruments (Class III);Implementation of a QMS and support with the certification of a monitoring software (Class IIa);Support with the regulatory analysis, QMS implementation and certification (Class C).In order to fulfill your mission, you will need:Good understanding of Medical Devices and IVD regulatory environment (directives, regulations);Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards;Speak French/Dutch and English to communicate with our clients and our cosmopolitan team;Make clients' satisfaction a priority by combining quality and professionalism;Driving licenseEvery seniority level is welcomeYou start your career? Our team will be there to guide you You will collaborate on several projects and you will quickly have an overview of what can be done here. Cherry on top: you will learn and discover a lot in a short timeYou have got a first experience already? We will support you in the development and the enhancement of your knowledge and know-how. You will become more and more autonomous, take the lead on your projects, and coordinate team work.You have got a proven experience? We will be happy to make our clients and colleagues benefit from your expertise You will get introduced to our methods then you will take the full lead on challenging projects.HomeworkingWe know that homeworking is a must nowadays. However, when several people work on the same project, the office remains the best option for interactions, ideas, and pieces of advice sharing. Same for the coaching which is essential during the first months.Once you have become more autonomous, you will apply for one or two days per week at home.Our offerIn addition to your salary, you will get meal vouchers (10 euros/day), a good health covering and pension plan, as well as 50% of public transport costs.Training:On your arrival and all along your career at COVARTIM, you will get many opportunities for learning (technical topics and soft skills).Well-being at work:At COVARTIM, we care for our members' well-being:Attentive director and managers;Weekly monitoring of mood and feelings;A comfortable and colorful office;A good balance between work and life;Activities that strengthen group cohesion and make the atmosphere even more pleasant (after-works, team-buildings, puzzles, sport sessions, …);And cherry on top: one well-being workshop per quarter (yoga class, nordic walk, seated massage, cooking class, ...).ApplyGet to know us better and apply on Welcome to the Jungle:Or send your application and resume to:Kyun ThibautPDGjobs@covartim.comRecrutement process:STEP 1(20 minutes)First call with Kyun to make sure that the job meets your expectations and to fix an interview.STEP 2(30 minutes)Call with Aurore, Team Leader, to discuss the job more deeply.STEP 3(60 minutes)Interview with Kyun in our office in La Rochelle to take a quick test (case study) and to discover our office and our team members. #J-18808-Ljbffr