Quality Assurance Engineer

**Quality Assurance Engineer**

**Therapixel - a leading software company 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 a challenging work environment driven by talented people who share the same vision and passion.

Our strong sense of mutual commitment creates synergy pushing away all medical imaging limits.
- **A newly created position to**_**to reinforce our Quality Assurance 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_

**More details about the position**:
The 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.

The role of 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 release
- Supporting the preparation of documents for regulatory submissions under Regulation (EU) 2017/745 (MDR) and FDA
- Performing the risk assessments pertinent to each product
- Ensuring the conformity of the devices in accordance with the quality management system under which the devices are manufactured, before a device is released.
- Managing and controlling changes made to the product (Change control)
- Gathering post-market data and keep technical files updated
- Creating, assessing, resolving/ensuring the resolution of non-conformities, Corrective Actions, and Preventive Actions related to the products
- Coordinating Field-Safety Corrective Actions.
- Reviewing applicable regulations and ensuring Therapixel is compliant
- Maintaining up-to-date knowledge of standards and regulations and anticipating regulatory changes

The 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 have**:_
- A degree in a relevant scientific discipline, biomedical engineering preferred.
- Certification or professional training in:

- _ISO 13485_
- _ISO 14971_
- _IEC 62304, IEC 62366_
- _Regulation (EU) 2017/745 on medical devices_
- Several years of professional experience in regulatory affairs or quality management systems relating to medical devices, Software as a medical device (SaMD) preferred.

**Some essentials you need to have**:

- Appetite for understanding technology and products.
- Ability to learn and understand quickly and analyze complex documents and requirements.
- Ability to write clearly technical documentation.
- Good interpersonal skills. Able to work as part of a team and propose solutions.
- Good organizational and planning skills.
- Rigorous, with a good attention to detail.
- Proficiency with MS Office (Word, Excel, PowerPoint), Google WorkSpace, or similar tools.
- English and French language to professional working level.
- Knowledge 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 TYPE2
- **This is an exciting opportunity if you are**:_
- self-starter, autonomous, hands-on, pro-active, with can-do attitude
- low ego, collaborative, initiatives taking but not in isolation
- high accountability, ownership, no “not-my-job”
- **What Therapixel’s team expect from you**:_
- Thrive for excellence
- Creative, curious, and ingenuous
- Passionate
- **Our working conditions.....**_
- A convivial and flexible working environment, with a remote culture.
- Supportive environment (hiring, retaining, and promoting women is an integral part of our company’s culture).
- “People First” culture.
- A company culture based on autonomy & accountability
- Lunch card Swile, participation in your work-to-home travel expenses, sport membership participation, 100% participation in health insurance for you and your family.
- Annual company seminars to discover beautiful places and make strong connections.
- Offsites, after-work d