Site Quality Leader

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 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 will do

You will lead the local quality team, fulfilling all obligations of the local Quality System. Provide accurate reporting on and site representation for the site of responsibility to the Head of Quality. Ensure any/all known compliance gaps are addressed and resolved according to documented procedures and regulatory requirements expectations.

Specifically, you will:

• Partner with the Site Leader in running business operations
• Act as the site Management Representative
• Host external audits
• Hold quarterly management reviews
• Monitor site quality performance KPIs
• Report on KPI performance as required
• Ensure CAPA/SCAR/NC timeliness requirements are met
• Ensure Training curricula are accurate and appropriate for the employees within the site
• Ensure temporary/contract employees are trained to the same level as employees
• Provide guidance on quality matters pertaining to the site
• Ensure product issues are addressed immediately
• Ensure the internal audit program is executed appropriately and on schedule
• Interact with regulatory bodies, ensuring required communications are maintained
• Responsible for maintaining and remaining within operational budget
• Ensuring employees are managed appropriately, including taking disciplinary action when required
• Ensure the site leader is adequately informed of quality issues/activities 
• Where intra-site relationships are in place, ensure requirements of those relationships are maintained (via ICQAs, Supplier Agreements, or other appropriate means of responsibility delegation)


Who you are

• Bachelor’s Degree plus 12-15 years’ experience in varying roles within Quality in the Medical Device field.
• Working knowledge of FDA 21 CFR 820 and Part 11, ISO 13485:2016, ISO 14971, ISO 19011, EU MDR regulations, and in-depth understanding of the MDSAP audit methodology.
• Capability to lead and influence others in a global, matrix-style organization.
• Effective communication and influence skills
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 and Co-founder, Yann Fleureau (only if you did not have the opportunity to meet him in one of the previous interviews)