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QA Validation Engineer - H/F

Permanent contract
Salary: €45K to 50K
A few days at home
Experience: > 2 years

Volta Medical
Volta Medical

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The position

Job description

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 8 years ago and our team now has more than 120 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 !
  • Missions

  • Reporting to the Director of Quality Assurance and Regulatory Affairs, the QA Validation Engineer will be responsible for ensuring compliance with all regulatory requirements throughout the entire lifecycle of computerized systems, including specifications, project, operational, and retirement phases, as well as equipment qualification and maintenance. As the Process Owner for CSV and equipment management, the engineer reviews and approves key documents such as Standard Operating Procedures (SOPs), user requirements, risk analyses, validation plans, tests, changes, deviations, and more, ensuring adherence to regulations, guidelines, company policies, and standards. Key responsibilities include: 
  • Regulatory Compliance:

  • Ensure all CSV-related regulatory requirements are fulfilled during the complete lifecycle of computerized systems.
  • Maintain and apply up-to-date knowledge of international laws, guidelines, and new developments related to CSV.
  • Documentation and Approval:

  • Review and approve CSV documents to maintain compliance with regulations, guidelines, company policies, and standards.
  • Audit and Inspection Preparation:

  • Prepare for computer system audits and inspections.
  • Serve as the spokesperson for CSV-related matters during audits and inspections.
  • Perform and follow up on internal and external audits to ensure regulatory compliance.
  • Collaboration and Support:

  • Cooperate with engineering, IT, and other teams for the introduction of new systems and processes.
  • Provide advice and support for CSV-related activities, ensuring cGMP aspects are considered in new projects.
  • Participate in multi-functional teams to achieve cross-departmental objectives.
  • Profile

  • Master’s degree in Computer Science, Engineering, or related field.
  • Minimum of 2 years of experience in Computer System Validation
  • Strong understanding of regulatory requirements
  • Experience developing and implementing CSV strategies and programs.
  • Excellent communication skills, with the ability to work effectively with diverse teams Fluency in English and French.
  • Recruitment process

  • Phone call with our Talent Acquisition Specialist (30’)
  • Interview with our Senior VP Clinical, Quality & Regulatory Affairs and QARA Director (60')
  • Case study 
  • Culture fit interview with our Global VP People and Volta ambassador (60’)
  • What we can offer you at Volta Medical

  • 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.

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    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.

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