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Il y a 2 mois
We are seeking a highly skilled and experienced Senior QA Engineer to join our dynamic and distributed team at Eko Devices. As a Senior QA Engineer, you will play a crucial 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
- 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
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 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.
