Descripción de la oferta
Position Mission To support, maintain and continuously improve Altum Sequencing’s Quality Management System (QMS), ensuring compliance with applicable regulatory and accreditation standards. The Quality Specialist will play a key operational role in quality assurance activities, contributing to the reliability, regulatory readiness and continuous improvement culture of the organization. Roles and Responsibilities This section outlines the key roles and responsibilities required for the competent performance of the position within Altum Sequencing. · Support the implementation, maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 15189, ISO 13485 and other applicable regulatory requirements. · Manage and maintain controlled quality documentation (SOPs, templates, technical instructions), ensuring version control, traceability and compliance with document control procedures. · Support the management of non-conformities and customer complaints, including documentation, root cause analysis and follow-up of corrective and preventive actions (CAPAs). · Participate in internal audits, including preparation, execution, documentation of findings and follow-up of corrective actions. · Support external audits, inspections and assessments by regulatory bodies, notified bodies, customers or accreditation entities. · Coordinate and monitor training activities, ensuring personnel competence, training records completeness and compliance with QMS requirements. · Collaborate with laboratory, bioinformatics, R&D and regulatory teams to ensure quality requirements are integrated into daily operations and projects. · Support risk management activities, including risk identification, assessment and documentation related to laboratory processes, software, data handling and clinical workflows. · Contribute to quality indicators (KPIs) monitoring, data analysis and reporting during management review and quality meetings. · Promote a culture of quality and continuous improvement across all teams. Requirements The following requirements define the essential qualifications, skills and attributes necessary to successfully perform this role at Altum Sequencing. · Bachelor’s or master’s degree in Life Sciences, Biology, Biotechnology, Pharmacy, Chemistry or related field. · Previous experience (minimum 1-3 years) in a Quality and compliance role within a clinical laboratory, biotechnology, medical device or regulated healthcare environment. · Good knowledge of Quality Management Systems and applicable standards (ISO 15189, ISO 13485; ISO 9001 desirable). · Experience with document control systems, CAPA management and audit processes. · Strong attention to detail, problem-solving, organizational skills and documentation discipline. · Ability to analyze issues, identify root causes and support implementation of corrective and preventive actions. · Good communication skills and ability to work collaboratively in multidisciplinary teams. · Proactive mindset, continuous improvement orientation and ability to manage multiple tasks. · Proficiency in standard office tools and digital quality management environments. · Fluent English and Spanish.
