29 sep
Altum sequencing
Leganés
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.
- Adaptable working hours.
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