#### **Your mission** **Indivi** is a TechBio company enabling precision and personalised medicine to become a reality in neuroscience research and development. We are going through significant growth and looking for new team members who want to contribute to making our vision — *making measurable what is not so* — a reality. #### **Your profile** **As Head of Testing,** you will play a key role in driving the overall Verification and Validation (V\&V) strategy across our complex Digital Health products. You will ensure excellence in product quality, data integrity, and regulatory compliance while fostering collaboration across cross\-functional and distributed teams. You will lead both manual and automated testing resources and activities, coordinate V\&V planning and execution, and oversee the delivery of robust, validated, and compliant releases that meet the highest standards of safety and performance in a regulated environment. This position is ideal for a professional with strong leadership and coordination skills, experienced in V\&V or QA management, and motivated to build a collaborative, high\-performance testing culture. **This is a full\-time, on\-site role based in Córdoba, Spain.** #### **Key Responsibilities:** * **Team Leadership \& Development** + Recruit, structure, and develop the V\&V organization, including manual and automation testers. + Build a data\-driven culture that emphasizes traceability, evidence, and reproducibility in testing. + Coach and mentor engineers to embed quality and validation best practices into daily operations. + Foster collaboration, motivation, and accountability across distributed teams. * **Verification \& Validation Management** + Plan, coordinate, and monitor all V\&V activities + Define and execute a balanced strategy combining manual and automated testing, ensuring coverage of functional, performance, and data validation aspects. + Ensure each release follows established quality procedures, including traceability, testing evidence, and documentation sign\-off. + Review and approve all V\&V documentation (plans, protocols, reports, validation summaries) in alignment with ISO 13485 and IEC 62304 standards. + Oversee internal and external V\&V resources, including contractors and test laboratories. * **Data Validation \& Quality Assurance** + Establish robust processes for data validation, ensuring the accuracy, consistency, and integrity of clinical and operational data across systems. + Collaborate with Data Engineering and Product teams to define validation rules and test datasets. + Ensure validation evidence meets both regulatory and scientific standards of reproducibility. * **Cross\-Functional Collaboration** + Partner with Product Owners, Engineering, Data Science, and Regulatory Affairs to align on release scope, risk assessments, and acceptance criteria. + Act as the customer’s advocate, ensuring reliability, usability, and compliance are prioritized in development. + Support audits and inspections by maintaining documentation readiness and ensuring team awareness of compliance requirements. * **Continuous Improvement** + Identify opportunities to improve test efficiency, automation coverage, and data validation processes. + Drive initiatives that prevent defects early in the lifecycle rather than detecting them late. + Develop and deliver training programs to strengthen quality and validation competencies across teams. * **Execution \& Oversight** + Ensure timely and meaningful feedback on specifications and design documents. + Oversee the creation and maintenance of comprehensive V\&V test plans, protocols, and reports, with full traceability to the Risk Analysis Matrix and Design Control documentation. + Manage and prioritize QA/V\&V workload across multiple projects, ensuring consistent execution and alignment with scope, schedule, and quality goals. + Monitor and track defects and test metrics to drive continuous improvement. #### **Required Qualifications:** * **Education:** Bachelor’s or Master’s degree in **Computer Science**, **Information Technology**, or a related field. * **Experience:** 5\+ years in **Quality Assurance or V\&V**, including at least 2 years in a **team or project management** role. * Proven experience in **verification and validation** of **digital or regulated products** (e.g., medical device, pharma, fintech). * Solid knowledge of **validation and compliance frameworks** such as **GxP**, **ISO 13485**, and **IEC 62304**. * Strong understanding of the **software development lifecycle (SDLC)** and testing methodologies. * **Languages:** Fluent in **English and Spanish** (written and spoken). * Excellent **organizational, leadership, and communication skills** — able to **motivate, coach, and coordinate** diverse teams. * Proactive and collaborative mindset, comfortable working with **cross\-functional and remote stakeholders**. * Strong **documentation and analytical skills**. #### **Nice to Have:** * Experience with **Software as a Medical Device (SaMD)** or **Digital Health** platforms. * Familiarity with tools such as **Jira**, **TestRail**, and **Confluence**. * **ISTQB** or equivalent QA certification. * Experience managing **external or offshore QA/V\&V teams**. #### **Technical Skills:** * Strong knowledge of **software verification and validation methodologies** (manual and automated testing). * Experience with **test planning, traceability, and documentation** under regulated frameworks. * Familiarity with **testing tools** such as **Jira, TestRail, Confluence, Git**, and automation frameworks (e.g., Cypress, Playwright, Robot Framework). * Understanding of **SDLC**, **CI/CD pipelines**, and **DevOps collaboration**. * Ability to define and monitor **test metrics**, coverage, and defect tracking. * Experience with **data validation**, test data management, and API or backend testing. * (Formal and practical knowledge of testing methodologies.) #### **Soft Skills:** * Strong **leadership and coordination** abilities — able to motivate, coach, and develop teams. * Excellent **communication and stakeholder management** across technical and non\-technical functions. * Highly **organized**, detail\-oriented, and able to prioritize in fast\-moving, multi\-project environments. * **Analytical mindset** with a focus on root\-cause analysis and continuous improvement. * **Collaborative and proactive** attitude, comfortable working in distributed teams. * Balance of **decisiveness and empathy** — a confident leader and a supportive team player. #### **Industry\-Specific Skills:** * Understanding of **medical device regulations** and **Digital Health product lifecycles**. * Working knowledge of **ISO 13485**, **IEC 62304**, **ISO 14971**, and **GxP** frameworks. * Awareness of **data privacy and security** principles (GDPR, HIPAA). * Experience with **SaMD**, **clinical\-grade software**, or other **regulated industries** (pharma, biotech, fintech). * Familiarity with **risk\-based testing**, **design control**, and **audit preparation**. #### **About us** We are looking for highly motivated and experienced people with our like\-minded focus on improving the lives of people with neurological disease. **Indivi** is an equal opportunities employer and encourages applications from candidates of all backgrounds, particularly those from underrepresented groups. Reasonable adjustments will be made wherever possible. https://indivi.io