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 adecuado 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.
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