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Senior Quality Assurance Engineer

il y a 1 mois

Paris, Île-de-France Eko Devices Temps plein
About the Role

We are seeking a seasoned Senior QA Engineer to join our dynamic and distributed team at Eko Devices. As a Senior QA Engineer, you will play a pivotal role in ensuring the highest quality of our products and services across various domains.

Responsibilities:
  • Manage and validate QMS systems and software system test automation
  • Plan, lead, and execute quality projects and data initiatives, including feedback and complaints, nonconformities, software defects, CAPAs, KPIs, and PMS
  • Collaborate with stakeholders and system owners to drive quality improvements
  • Support medical device instrument and software development projects as QA stakeholder, focusing on design controls and risk management
  • Ensure compliance with international regulations and standards
Requirements:
  • Established commercial experience in Quality Assurance roles within the Medical Device industry, preferably in a management position
  • Deep understanding of Quality Management System principles and effective implementation
  • Demonstrated success in project delivery and technical writing
  • Strong background in risk management and Agile software development lifecycle processes
  • Exceptional analytical and problem-solving skills
  • Effective communication and teamwork abilities, essential for our remote-first environment
  • Extensive experience from driving continuous improvement efforts, preferably with multiple stakeholder groups
  • A product mindset, with a keen understanding of user needs and product lifecycle
  • Comprehensive understanding of international regulations and standards, e.g. EU MDR, FDA QSR, ISO 13485, IEC 62304, IEC 62366, and ISO 14971
About the Engineering Team

We are a distributed and remote-first company with a team of 40 full-time engineers working from various locations across Europe. Our headquarters and hardware development team are based in Stockholm, Sweden.

We strive to create a flexible workplace that focuses on work-life balance and encourages our engineers to achieve their goals without sacrificing everything else.

Our engineering team is divided into smaller cross-functional project teams, each focusing on a specific goal or target. We track goals on a yearly and quarterly basis and have a bi-weekly goal follow-up across the entire engineering organization.

We have a bi-weekly engineering demo where teams present their progress, failures, or hacks. We believe in our mission and value work-life balance, making Eko Devices an attractive place to work.