We believe the future of the operating room lies in the hands of the empowered surgeon. They are bolstered with complete control, renewed confidence, and technology adaptable to any situation.
Our Maestro System delivers this empowerment, resulting in improved operating room efficiency and surgical care for patients - We are using tomorrow's technology to change surgery today.
Our blended French-American team is passionate about building this future. Together we are pushing the boundaries in a fast-paced yet focused and deliberate environment. We challenge ourselves often and celebrate our achievements. We believe that communication and planning are as important as execution.
Your Core Responsibilities
As the guardian for the quality of our products and operations, and as a gateway to bringing our products to the market, you will :
Your Day-to-day Activities
Daily, you will be fully immersed in company design and manufacturing operations. You will build and manage our quality management system and all related activities. You will work across the organization to understand needs and architect a QMS that meets those needs efficiently and effectively. You will be heavily involved in executing product verification and validation, coordinating with our technical resources, instrumenting our design and manufacturing tools processes, and helping to prepare for scale-up.
How You’ll Fit In
Initially, you will report to our Chief Strategy Officer (CSO), until the Quality organization is expanded in the future. You will work with your manager to develop the organization's short, mid, and long-term projects. Daily, you will be in contact with team members globally, on an as-needed basis, with frequent interactions with management and technical resources.
You will be recruiting and managing your team, with resources based in the US and one in Paris.
The whole company meets globally a few times a year, and you will rapidly have an opportunity to meet everyone involved.
Start Date
Q3 2023
Confident in navigating without much clarity and guidance.
BS in Science, Engineering, or other relevant field of study
At least 5+ years of experience in Quality Assurance in the MedTech field
Formal training in Quality Systems.
Must be willing to travel (25%) and spend time in the operating room, cadaver, and animal labs and visit customers or teams in other geographies as needed
Working knowledge of 21 CFR 820.30, ISO 14971:2019, ISO 13486, IEC 60601, IEC 62304
Out-of-the-box thinker and problem solver
Demonstrated ability to work in cross-functional team environments.
Excellent communication skills
Excellent analytical skills.
Excellent interpersonal skills.
Demonstrated practical nagerial skills.
Excellent organizational skills.
Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
25 Days of Paid Vacation
12 Paid Holidays
Occasional domestic and international travel is required.
401k with matching
Competitive Vision, Dental, and Health benefits
