Quality Assurance

OverviewA newly created position to reinforce our Quality Assurance (QA) team. You are passionate about Quality Assurance applied to medical devices. You have several years of professional experience in regulatory affairs or quality management systems relating to medical devices.Show us you are the best candidateYOU WONDER WHO WE ARE?Therapixel is one of the leading French software companies specializing in artificial intelligence applied to medical imaging. Our goal is to provide radiologists with innovative software, designed with a high level of safety, quality, and performance, to help them improve their clinical practice. We are a multicultural, dynamic, and dedicated team. We create an energizing work environment driven by talented people who share the same vision and passion. We truly encourage diversity and gender inclusive work environment. Our strong sense of mutual commitment creates synergy pushing away all medical imaging limits. We develop technology for goodAre you ready to join us?ABOUT THE POSITIONThe Product department leads the products life cycle and the QARA department is a support department at Therapixel that ensures the efficacy, performance, and adequacy of the management systems, as well as regulatory compliance of the marketed products.Role: The Quality Assurance (QA) Engineer is to support the Product Managers and R&D Engineers in designing, developing and maintaining products using Therapixel’s Quality Management System (QMS) to ensure they are compliant with required regulations.As our Quality Assurance (QA) Engineer your Missions and Responsibilities, will be:Preparing the QA technical documents necessary for each product releaseSupporting the preparation of documents for regulatory submissions under Regulation (EU) 2017/745 (MDR) and FDAPerforming the risk assessments pertinent to each productEnsuring the conformity of the devices in accordance with the quality management system under which the devices are manufactured, before a device is releasedManaging and controlling changes made to the product (Change control)Gathering post-market data and keep technical files updatedCreating, assessing, resolving/ensuring the resolution of non-conformities, Corrective Actions, and Preventive Actions related to the productsCoordinating Field-Safety Corrective ActionsReviewing applicable regulations and ensuring Therapixel is compliantMaintaining up-to-date knowledge of standards and regulations and anticipating regulatory changesThe QA Engineer is also responsible for the regulatory release of minor and sub-minor (patch) versions. As a substitute of the QARA Director, the Quality engineer is responsible for the regulatory release of major versions, when the QARA Director is on leave.The QA Engineer is also the substitute Materiovigilance Correspondent for events that occur when the primary correspondent (the QARA Director) is unavailable.It’s necessary to haveA degree in a relevant scientific discipline, biomedical engineering preferredCertification or professional training in:ISO 13485ISO 14971IEC 62304, IEC 62366Regulation (EU) 2017/745 on medical devicesSeveral years of professional experience in regulatory affairs or quality management systems relating to medical devices, Software as a medical device (SaMD) preferredSome essentials you need to haveAppetite for understanding technology and productsAbility to learn and understand quickly and analyze complex documents and requirementsAbility to write clearly technical documentationGood interpersonal skills. Able to work as part of a team and propose solutionsGood organizational and planning skillsRigorous, with a good attention to detailProficiency with MS Office (Word, Excel, PowerPoint), Google WorkSpace, or similar toolsEnglish and French language to professional working levelKnowledge of information security standards and regulations would be appreciated:ISO 27001 / ISO 27018 / Applicable FDA guidance on cybersecurity applied to medical devices, including ANSI UL 2900-2-1. / HDS / GDPR / HIPAA / SOC2 TYPE2This is an exciting opportunity if you areSelf-starter, autonomous, hands-on, pro-active, with can-do attitudeLow ego, collaborative, initiatives taking but not in isolationHigh accountability, ownership, no “not-my-job”What Therapixel’s team expect from youThrive for excellenceCreative, curious, and ingenuousOur working conditions…A convivial and flexible working environment, with a remote cultureSupportive environment (hiring, retaining, and promoting women is an integral part of our company’s culture)A company culture based on autonomy & accountabilityLunch card Swile, participation in your work-to-home travel expenses, sport membership participation, 100% coverage of the health insurance for you and your familyAnnual company seminars to discover beautiful places and make strong connectionsOffsites, after-work drinks, celebration of our success to recharge, have some fun and build shared memories and a strong teamInternational working environnementLocation: Hybrid: our Paris office + remoteContract: permanentHere are the stages in our recruitment processDiscussions about your driving forces, your ambitions and our mindsetTechnical testsDiscussions with one or more members of the team, including your future managerDiscussions with our CEO or Chief People OfficerOur recruitment process is mainly conducted by videoconference.We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace. We are proud to foster a workplace free from discrimination. We encourage all qualified individuals to apply.PLEASE SEND YOUR CV AND A COVERING LETTER TO JOBS@THERAPIXEL.COM OR APPLY ↓ #J-18808-Ljbffr