Senior Quality Assurance Specialist, H/F, Marseille
Marseille
CLQARA – Quality /
CDI statut cadre /
Hybrid
đź«€Who are we ?
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 more than 100 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.
đź«€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 !
đź«€Missions
- We are looking for a Senior Quality Assurance Specialist to be part of our QA team. Extensive experience in a Software Medical Device company is mandatory.
- As a Senior Quality Assurance Specialist, you will be responsible for conducting quality-related activities to deliver consistent, high-quality documents, services, products and processes.
- Your mission :
- Ensure the management and improvement of the quality management system (QMS) to ensure compliance with applicable standards and regulations.
- Support the development, review, implementation and training of all relevant QMS procedures.
- Support the reporting and analysis of key performance indicators (KPI), including data collection, analysis and improvement action plan for all indicators.
- Coordinate the validation of computer system applications,
- Participate in the management of customer complaints, non-conformities and corrective/preventive actions, including implementation plans, root cause analysis, corrective actions and providing objective evidence for verification/closure.
- Provide strong support to R&D activities and participate in product development and change control.
- Support production processes and organization, and participate in product release,
- Actively participate in preparation and conduct of supplier, internal and external audits,
- Cross-functionality assisting Clinical and Regulatory Affairs colleagues, as needed.
đź«€Profile
- Relevant education background (master’s degree in Life Science, Engineering),
- Minimum 5 years of quality-related experience in a software medical device company,
- Strong experience with MDR 2017/745 and 21 CFR requirements,
- Extensive knowledge of medical devices standards (ISO 13485, ISO 14971, IEC 62366, IEC 62304, IEC 60601),
- Prior experience with Electronic Document Management and eQMS,
- Interest in IT, software and electronic tools, (including their validation)
- Experience participating in US and EU inspections/audits,
- Fluent in English,
- Strong leadership and collaboration skills,
- Excellent verbal and written communication skills,
- Scientific background appreciated,
- Solving problem attitude,
- Autonomy and attention to details.
đź«€What we can offer you at Volta Medical
- A salary ranging from €45,000 to €55,000 gross per year, depending on your profile
- A pleasant work environment, with ideally located offices in the 6th district of Marseille offering a beautiful 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, 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.
đź«€Recruitment process
- Pre-qualification Call with the HR team - 15’ (call)
- Interview with the QA Team Leader and the Sr VP of Clinical, Quality & Regulatory Affairs - 60’(in person)
- Technical or situational test (by email)
- Reference check
- Cultural Fit Interview with HR and a Volta ambassador - 60’ (in person)
The information that you provide is subject to personal data processing by Volta Medical as data controller for the purpose of managing your job application.
The information provided is for the use of Volta Medical’s recruitment team as well as other recipients (individuals and organizations) involved in the recruitment for the position that you applied for. Your information will be stored for the duration of the processing of your application. If you are not selected for the position, your information will not be stored, unless you consented to being included in our applicant database. In this case, your information will be stored for 2 years from the date of the submission of your application to enable us to contact you for future opportunities. Nevertheless, you have the right to withdraw your consent at any time.
As part of its activities, Volta Medical may transfer data to a country outside of the European Union with appropriate safeguards in place.
Volta Medical’s Privacy Policy provides more in-depth details about how your information is used and stored, as well as the legal bases that dictate the information processing that is carried out. The Privacy Policy also includes a reminder of your personal data rights and information on how to reach us with any questions or concerns.
