Quality Assurance Director

il y a 4 semaines

Marseille, France Volta Medical Temps plein

**Who are we ?**

Improving the lives of patients suffering from Atrial Fibrillation (a pathology causing an irregular heart rate) thanks to artificial intelligence ? It is possible

The creation of Volta Medical follows the discovery of a new complex medical procedure to treat atrial fibrillation (the most common cardiac arrhythmia in the world) by the company’s founders, world experts in interventional rhythmology and intracardiac signal analysis.

Volta Medical is an innovative start-up based in Marseille, whose goal is to provide a range of artificial intelligence-based products to guide the cardiologist during ablation-type procedures.

We started this adventure 7 years ago and our team now has nearly 70 employees in France, Germany and the United States We completed a $27 million Series A round in November 2020 and a $36 million Series B round in January 2023.

**Our values**:

- ** Be a pioneer**: Be brave. Don’t be scared of researching, exploring, trying and sometimes failing.
- ** Improve patients’ lives**: Create products to provide electrophysiologists with the best user-experience possible, to help them improve the lives of patients.
- ** Strive for excellence**: Push yourselves to deliver the highest quality in everything you do. Learn from your mistakes and aim for the best.
- ** Collaborate as a team**: Welcome to a multidisciplinary and a diversified team Try to understand people from different cultures and environments. Confront your ideas and have fun

**Mission**:

- You are a key member of the Clinical, Quality and Regulatory Affairs department, you will coordinate the quality team and be responsible for implementing the company's quality objectives and procedures, ensuring general consistency between the various departments.
- Under the responsibility of the Vice-President of Clinical & Regulatory Affairs, the Quality Assurance Director will be responsible for:
- Define the quality policy and suggest it to the management team
- Promote quality within the company
- Supervise the definition of methodologies, tools and indicators used to periodically assess the quality system and control the compliance of quality system processes
- Ensure the conformity of manufactured products and contribute to the control of production processes, in particular by defining production control activities
- Supervise the management of non-conformities and corrective/preventive actions
- Supervise the management of subcontractors and suppliers
- Plan and control the implementation of the various audits (internal, external, subcontractors)
- Manage the human resources of the team (3 people) and the quality budget
- Manage professional relations and communication with certifying bodies and authorities.

**Profile**:

- You are a graduate of a higher education such as an Engineering School or a Masters in Regulatory Affairs/Quality Assurance DM,
- You have at least 8 years of experience in Quality Assurance in an active medical device company (hardware/software),
- You speak fluent English (daily exchanges in writing and orally),
- You master the ISO 13485 standard, 21 CFR 820, regulation 2017/745/EU,
- You have experience in the industrialization and production of electromedical devices,
- You have an auditor certification and/or significant experience in internal/external audits,
- You have experience in team management,
- You have good communication skills and diplomacy,
- You are a mediator and facilitator, with charisma and leadership,
- You have excellent analytical and writing skills,
- You are rigorous and methodical.**What we can offer you at Volta Medical**:

- A fixed gross compensation ranging between 55K€ and 60K€ a year as well as a variable part, both depending on your profile
- A pleasant work environment, with ideally located offices in the 6th district of Marseille offering a magnificent view upon Notre Dame de la Garde and the Mediterranean Sea.
- The possibility of working from home 2 days a week
- Passionate colleagues that have the same goal in mind: improve patients’ lives
- A corporate culture based on innovation, empowerment and collaboration.
- An international environment that allows you to practice your best american accent
- Prospects of ambitious evolutions with various internal mobilities
- Regular team building events, breakfasts for gourmands and for the people enjoying sport activities, free weekly yoga classes and preferential rates for a gym subscription.
- And more traditional advantages: a lunch voucher card (Swile), a good health insurance (Malakoff Humanis), a vacation bonus, RTTs in addition to paid vacation, as well as exceptional days of absence on top of those provided in the collective agreement (compensation hold in case of illness starting from 6 months of seniority, additional days for a sick child, moving leave, etc.)

Join a company on a human scale, whose operations leave room for initiative and innovation in the service of patients.**Our re

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