Overview
Quality Assurance Engineer Jobs in Paris, Île-de-France, France at PROJECTUS
Title: Quality Assurance Engineer
Company: PROJECTUS
Location: Paris, Île-de-France, France
Our client is one of the driving companies using state of the art Artificial Intelligence
within the world of medical imaging and software.
The software available to Radiologists and other consultants in lab, ensures a safe
high performing solution.
This helps them improve their clinical practice!
The new Quality Assurance Engineer is a new position, created to reinforce the QA
team.
KEY ACCOUNTABILITIES:
The role of the Quality Assurance (QA) Engineer is to support Product and R&D in
the designing, developing and maintaining of company products using the Quality
Management System (QMS).
Additional duties include:
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 the company 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.
SKILLS/EXPERIENCE REQUIRED:
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
2+ years’ of professional experience in regulatory affairs or quality
management systems relating to medical devices, Software as a medical
device (SaMD) preferred
2+ years of experience in applying ISO13485 standard to medical devices
design.
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
