Validation Manager, Medical Software
In order to advance this great project, the QRA team is looking for its future Validation Manager.
Who are we?
Our purpose: to become the reference for tomorrow’s surgery by providing medical teams with the power of digital technologies.
Our know-how: to develop innovative solutions to assist clinical decisions and surgical procedures that meet the needs of surgeons and their teams. We uniquely combine real-time 3D web-based simulation technologies, mixed reality, remote collaboration, and also artificial intelligence or 3D printing for predictive and personalized surgery. For this ambitious mission, our quality management system is certified according to ISO 13485 and we obtained our first U.S. market authorization in December.
Our « dream team »: 30 people who take on any challenge with kindness & humor.
Your advantage: unlimited access to the gentle way of life in La Rochelle, its lunches on the beach and its afterworks on the port.
To ensure that the next challenges rhyme with success, the Quality & Regulatory Affairs team is looking for its future Validation Manager, Medical Software.
Your missions will be the following:
- Establish the test strategy to ensure the verification and validation of medical software devices for healthcare personnel (mainly surgeons): Functional validation / Performance validation / Validation of fitness for use
- Contribute to the writing and execution of tests;
- Contribute to the implementation of automated tests.
- Contribute to risk analysis of software medical devices;
- Participate in the elaboration of technical files to obtain marketing authorizations in Europe and the United States (CE and FDA). ;
- Manage the medical device software validation team;
- Raise awareness of good testing practices among all teams.
Your mission field will be marked out by the quality standards related to medical software (IEC 62304 / 82304 and lSO 13485 in particular) and the regulations related to medical devices (Regulation (EU) 2017/745 and 21 CFR Part 820).
The basic ingredients
- You have a degree in software engineering or software quality assurance;
- You have a minimum of 5 years of experience in software product testing;
- You master the design of test plans and the execution of these tests in different software environments;
- You have experience in test automation;
- You are fluent in professional English;
- You have an appetence for team management
The dose of softskills
- Rigor is part of your work DNA and you are known for your reliability.
- You have a solid capacity for organization and prioritization.
- You are dynamic, reactive and have a strong sense of initiative.
- You like teamwork and you know how to motivate the people you work with.
The icing on the cake
- You have experience in testing in a normative environment.
Type of offer
📄 Permanent contract
📅 August 2023
💰 Remuneration according to profile from 40k€.
📌 In La Rochelle with 2 days of telecommuting per week
1.HR interview with Camille, our Human Resources Manager (30’)
2.More advanced interview with Quentin, our Quality & Regulatory Affairs Project Manager(1h)
3.On-site interview with different team members (1/2 day)