Descripción de la oferta
Your mission
Indivi is a TechBio company enabling precision and personalized 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).
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.
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