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Senior Quality Assurance Engineer

Il y a 2 mois


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

We are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our dynamic and distributed team at Eko Devices. As a Senior Quality Assurance Engineer, you will play a crucial role in ensuring the highest quality of our products and services across various domains.

Key Responsibilities
  • Manage and validate Quality Management System (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 team of 40 full-time engineers, working from various locations across Europe. Our headquarters and hardware development team are based in Stockholm, Sweden. We are a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else.

Organization and Way of Working

The engineering team is divided into smaller cross-functional project teams that each focus on a specific goal or target. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams. Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else.