QA Engineer

Paris, FR /
Regulatory Affairs & Quality Assurance /
Full-time
/ On-site
At Cardiologs, we aim to democratize access to expert cardiac care through medical-grade artificial intelligence and cloud technology. Our flagship product, the Cardiologs Holter platform, is a leading software for analyzing ambulatory ECG used to help diagnose over 1.8 million patients annually.
 
We are currently venturing into the remote patient monitoring space with the Cardiologs RPM solution, allowing patients to share their smartwatch ECGs with their physicians, who in turn use our cloud-based RPM platform to streamline ECG reviews.
 
In November 2021, we announced that we were being acquired by Philips to expand our cardiac portfolio.
 
We have an innovative, result-oriented work environment where we foster ambition and dedication while being mindful of our teammates’ work and achievements. We also nurture our company culture with monthly all-hands meetings and apéros, and other fun activities. 

What you’ll do

We are looking for a Quality Engineer to lead and coordinate different Quality topics, such as:
- Customer Complaints process & Vigilance,
- Post-market activities (PSUR),
- Release process,
- Supplier management,
- NC & CAPA management.

You will also support QMS continuous improvement.

You will:
- Conduct, coordinate with appropriate teams, and document complaint assessments and investigations per company complaint handling procedures.
- Realize reportability assessment, lead and coordinate vigilance activities where required.
- Proactively monitor and trend customer data and specific complaints data for statistical trends, communicate and recommend corrective action to appropriate teams. Drive and document post-market analysis as required by the regulation.
- Participate in release documentation management. Lead supplier process and perform yearly evaluation.
- Lead and coordinate NC and CAPA processes.
- Participate actively in QMS improvement. Seek and drive continuous improvement initiatives.

Who you are

- You have a bachelor’s degree in Science or a related field of study or related experience in the medical device/pharmaceutical industry.
- You have (ideally) two years of experience in the medical device or pharmaceutical quality assurance field. 
-  An autonomous, committed, enthusiastic person with a “can-do” and challenging mindset.
- You have knowledge of the normative and regulatory environment related to medical devices.
- You have strong analytical and persuasive skills.
- You want to work in an ambitious and rapidly growing company.
- You are fluent in English and have a good level of French.
What we value
 
We value a positive mindset, collaboration, a sense of ownership, transparency, the ability to embrace ambiguity, a talk-less-do-more attitude, and a sense of humor to enjoy ourselves along the way. If you identify with our values and want to contribute to our company, we’d love to have you in!
 
What we offer
 
- Beautifully by-the-book startup offices in central Paris (we are in the 2nd arrondissement) 
- A respectful, fun, collaborative work environment
- Flexible WFO/WFH policy
- Lunch vouchers (Swile card)
- Daily fresh fruits and healthy (or not) snacks
- Monthly apéros
- Yearly team off-sites
 
Our recruiting process
Being authorized to work in the EU is a precondition of employment.
 
1- Quick introductory HR phone call (20-30 min)
2 - Technical interview in our office or by Zoom with the Hiring Manager and a team member (90 min)
3 - Performance interview in our office or by Zoom with 2 different persons from the team (90 min)
4 - Culture interview (with lunch or drinks with the team if possible!) with 2 different persons from the team (90 min)
 
To close the process, we'll do some reference calls. In parallel, we'll organize a quick call (15-20 min) with our General Manager, France Schwarz (only if you did not have the opportunity to meet her in one of the previous interviews)