Computerized System Validation Engineer

il y a 1 semaine

Marseille, Bouches-du-Rhône, France Volta Medical Temps plein

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 Computerized System Validation (“CSV”) 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 defines the validation strategy as well as he writes, 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:


  • Validation:

Ensure all CSV-related regulatory requirements are fulfilled during the complete lifecycle of computerized systems.

Actively participate to CQV projects or activities definition, planning or execution and execute commissioning and qualification validation protocols: IQ, OQ, PQ.

  • Documentation:

Define CSV strategies and planification.

Writing support, review and approval of CSV and CQV documents (specifications, risk analysis, protocols, reports, traceability matrix) to maintain compliance with regulations, guidelines, company policies, and standards.

In charge of related SOPs writing and improvement.

  • Audit and Inspection Preparation:

Prepare for audits and inspections.

Serve as the spokesperson for CSV- and CQV-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, production and other teams for the introduction of new systems, equipment and processes.

Provide advice and support for CSV- and CQV-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 and/or CQV strategies and programs.
  • Excellent communication skills, with the ability to work effectively with diverse teams
  • Analytical skills
  • 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’)

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