• Manage the development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection • Design experiments to understand sources of variation affecting products and processes • Applies statistical process control (SPC) methods for analyzing data • Design and perform experimental product testing and analysis • Generate and analyze reports and defective products • Direct and collaborate with supplier representatives on quality problems • Lead supplier qualifications • Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files • Responsible for building appropriate product documentation in compliance with applicable regulations • Coordinate product testing with internal and external laboratories • Ensure compliance with domestic and international regulations • Perform quality reviews of design documentation • Lead investigations of product and process non-conformances and develop effective corrective actions

• Manter processos de QA alinhados às melhores práticas de mercado (Shift-left, CI/CD, Quality Gates). • Seguir padrões, guias e frameworks de testes • Planejar, projetar e executar as iterações de testes, sejam elas funcionais, exploratórios e regressivos. • Desenvolver e manter suítes de automação API • Aplicar testes não funcionais quando necessário, como carga, stress, segurança e usabilidade. • Integrar testes automatizados aos pipelines de CI/CD. • Participar ativamente de code reviews relacionados a testes e padrões de automação. • Formalizar, investigar e acompanhar defeitos até sua resolução. • Realizar análise de causa raiz (RCA) e apoiar times no aumento da qualidade preventiva. • Trabalhar em parceria com áreas de Produto e Desenvolvimento • Apoiar processos de Release e validações finais.

Role Description We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security. The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement. Qualifications - Ability to communicate effectively in English (spoken and written) - Ability to work independently, take initiative, and meet deadlines - Capable of prioritizing and executing tasks in a high-pressure environment - Demonstrated collaboration skills across diverse teams and functions - Adaptable and productive in a dynamic, evolving environment - Proficiency with Microsoft Office applications - Bachelor’s degree in life sciences, computer science, or a related field - Minimum of 5 years of QA experience in clinical research, clinical systems, or regulated software environments - Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles - Proven experience in conducting audits and managing CAPAs - Excellent documentation and communication skills - Preferred: Experience in a company offering eClinical or biometric services - Preferred: Familiarity with electronic QMS platforms such as ZenQMS Requirements - Conduct and/or host internal audits and vendor audits - Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance - Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions) - Perform risk-based audit planning and inspection readiness assessments - Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents - Ensure alignment with the company’s Quality Policy and applicable external regulations - Ensure controlled documents are reviewed periodically and in a timely manner - Document and manage deviations, nonconformances, and CAPAs - Maintain quality records and support archiving in accordance with regulatory timelines - Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams - Monitor overdue training, and follow up with individuals and their supervisors until completion - Participate in validation planning and execution for internal and customer-facing systems - Collaborate with software validation team and IT to review validation documents - Review change requests, bug reports, and ensure re-validation as needed - Ensure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures - Plan, execute, and document internal process audits, project/study audits, and vendor audits - Coordinate with IT and product teams to ensure systems and environments are audit-ready - Lead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA) - Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks - Act as a QA liaison across departments, including Biometrics, Software Development, and IT/Security - Mentor junior QA team members by providing training and peer reviews - Represent QA in project meetings, product releases, and client quality discussions - Lead or contribute to risk assessments for clinical projects, software systems, and vendor engagements - Identify quality gaps or inefficiencies and propose remediation or process improvement initiatives - Monitor and analyze quality metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness) - Contribute to QMS improvement projects and ensure effective cross-functional adoption Benefits - Choice of comprehensive Medical, Vision and Dental Insurance plans - Paid vacation time and sick days - Corporate holidays annually - Participation in the 401K Plan - Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. - Health Advocate and Employee Assistance Program Location This is a remote position, and we are open to candidates based in South America. Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.

Role Description We are looking for a QA Engineer with solid experience in software testing, preferably with exposure to embedded systems. In this role, you will be responsible for executing manual tests as well as expanding and maintaining our existing automation coverage. Responsibilities and Duties - Define requirements for test environments, data, resources, and tools - Create and maintain traceability matrices - Provide accurate high-level and detailed estimations for assigned activities and features - Develop and execute Test Plans in line with standards - Ensure automated test coverage (execution, analysis, reporting) - Contribute to the development and expansion of the existing Python test framework - Interpret and apply product and project metrics (technical and quality) - Prepare Test Summary Reports for features and programs in line with standards - Monitor, update, and implement new QA approaches based on standards (ISO/IEC/IEEE, ISTQB, RST) - Apply Quality Management principles (Planning, Assurance, Control, Continuous Improvement) Qualifications - 3+ years of experience in manual testing - Strong knowledge of testing methodologies and test documentation practices - Experience with bug tracking systems - Hands-on experience in UNIX/Linux, including CLI navigation and use of regular expressions - Experience with databases and SQL - Experience with CI tools (Jenkins) - Practical experience with API testing (CRUD operations, debugging with Postman or similar tools) - Basic automation skills with Python (ability to read a script or maintain simple tests) - Good written and spoken English Nice to have - Understanding and hands-on experience with embedded systems testing - Familiarity with AWS services - Basic experience with Raspberry Pi - Hands-on experience in Bash scripting - Basic knowledge in computer vision and machine learning - Experience in mobile testing Benefits - The environment of equal opportunities, transparent and value-based corporate culture and an individual approach to each team member. - Competitive compensation and perks. Annual performance review. - Opportunity to receive a Performance Bonus for your individual achievements and a Loyalty Bonus recognizing your dedication to the company. - Gig-contract. - 21 paid vacation days per year, paid public holidays according to the Ukrainian legislation. - Development opportunities like corporate courses, knowledge hubs, and free English classes as well as educational leaves. - Medical insurance is provided from day one. Sick leaves and medical leaves are available. - Remote working mode is available within Ukraine only. - Free meals, fruits, and snacks when working in the office.