Quality Assurance Specialist (Leganés) | (V534)

Quality Assurance Specialist (Leganés) | (V534)

At Altum Sequencing, we are dedicated to transforming cancer diagnostics and monitoring through cutting-edge genomic technologies. As Quality Assurance Specialist your mission is to establish, implement, and continuous improve of a robust Quality Management System (QMS) aligned with UNE-EN ISO 15189 and UNE-EN ISO 13485, supporting medical device development activities (IVD) at Altum Sequencing.

The QA Specialist will play a key role in the implementation of ISO 13485 of in vitro diagnostic products, enabling the company to deliver reliable, compliant, and high-quality solutions to patients and clinical partners.

Tasks

Roles and Responsibilities:

Quality Management System (QMS) and Compliance and Accreditation:





- Implement and maintain the Quality Management System (QMS) following ISO 13485, IVDR and ISO 15189 standards.
- Support the company in the certification process for ISO 13485 for in vitro diagnostic products.
- Ensure documents, procedures, and records are up to date and compliant with regulatory requirements.
- Collaborate in internal audits, follow up on non-conformities, and support corrective and preventive actions (CAPA).
- Work closely with Regulatory Affairs, R&D;, Laboratory, and external partners to ensure quality is present in all processes.

Process and Risk Management:

- Identify, assess and mitigate risks that could affect the quality of laboratory results.
- Support process improvements through quality planning, risk analysis and statistical monitoring.

Training and Competence:

- Organize training related to quality and ensure personnel competence is documented and up to date.
- Promote a culture of quality and continuous improvement across all teams.

Quality Data Management:

- Track, analyze and report quality metrics e.g. open/closed/overdue Non-Conformities,



CAPA, customer Complaints, Change Controls and Documentation.
- Monitor performance indicators and initiate quality improvement initiatives as needed.

Client and Stakeholder Communication:

- Address quality-related client concerns or complaints professionally and promptly.
- Ensure clients and collaborators receive high-quality, validated and reproducible laboratory data.

Requirements

- Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacy, Engineering or related field.
- Minimum 3–5 years of experience in QA roles within clinical laboratories, medical device companies or biotechnology environments.
- Proven knowledge and hands-on experience with ISO 13485, IVDR, ISO 15189, and GDPR (General Data Protection Regulation) and GCP (Good Clinical Practices).
- Excellent organizational, problem-solving,



documentation and communication skills.
- Experience with audit preparation and CAPA systems.
- Proficiency in quality software tools and document control systems.

Benefits

- Mission-Driven Impact – Be part of a team fighting cancer through cutting-edge liquid biopsy and MRD technologies.
- Deep Tech Environment – Collaborate with top scientists and engineers at the forefront of bioinformatics and NGS innovation.
- Flexible Work Setup – Hybrid and remote options available, with core hours adapted to scientific workflows.
- Continuous Learning – Access to conferences, courses, and internal knowledge-sharing sessions.
- Collaborative Culture – Work cross-functionally with clinical, R&D;, and product teams in a fast-growing startup.

At Altum Sequencing , we believe that our people are our most valuable asset.



We are committed to creating a purpose-driven, inclusive, and rewarding environment where scientific talent can thrive and contribute to real impact in patients’ lives. As a member of our team, you will benefit from:

Mission-Driven Work

- Be part of a cutting-edge company focused on transforming cancer care through precision diagnostics and real-time MRD monitoring.
- Contribute to meaningful projects that directly impact clinical decisions and patient outcomes.

Professional Growth & Development

- Work in a multidisciplinary, innovation-driven environment where learning and collaboration are at the core.
- Access to internal and external training opportunities, including certifications, conferences, and scientific development.
- Defined career progression pathways,



with the opportunity to take on increasing responsibility and leadership.

Modern, Dynamic Workplace

- A fast-paced biotech start-up culture with a strong focus on agility, creativity, and teamwork.
- Access to state-of-the-art laboratory infrastructure and technologies, including advanced NGS platforms and automation systems.

Inclusive & Collaborative Culture

- Flat organizational structure that encourages ownership, open communication, and idea-sharing.
- A supportive team where your voice is heard and your contributions are recognized.

Stability with Flexibility

- Competitive salary package, aligned with your experience and the impact of your role.
- Flexible working hours.

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📌 Quality Assurance Specialist
🏢 Altum sequencing
📍 Leganés

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