Quality Assurance Specialist

• 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.

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

• 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.

• 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.

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

• 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.

• 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.

• 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.

• 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.

• 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.

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

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

Altum Sequencing