Quality Assurance Specialist at Altum Sequencing

Leganés, Community of Madrid, Spain -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 26

Salary

0.0

Posted On

05 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 13485, IVDR, ISO 15189, Regulatory Affairs, Risk Management, CAPA, Training, Quality Data Management, Client Communication, Problem-Solving, Documentation, Communication Skills, Audit Preparation, Quality Software Tools, Document Control Systems

Industry

Biotechnology

Description

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.

Responsibilities

The Quality Assurance Specialist will establish, implement, and continuously improve a robust Quality Management System (QMS) aligned with ISO standards. They will support the certification process for ISO 13485 and ensure compliance with regulatory requirements.