SENIOR QUALITY ASSURANCE TECHNICIAN

Total fundraise $57ml. Most recent round $20ml.Today, fertility clinics help people make babies. But one of the bottlenecks of fertility is the embryology lab. It is an extremely laborious manual process, as embryos are made by hand. We are addressing this head-on by automating the embryology lab—the heart of every IVF clinic—to standardize and improve all processes from egg and embryo freezing and thawing to embryo making and more.Our goal is to drive up success rates in IVF by improving every aspect of the embryology lab to allow more people to walk home with a baby after embarking on IVF.Job OverviewThe QA Technician Senior will support the Quality department by ensuring compliance with internal and external quality standards and regulatory requirements. This role involves working closely with cross-functional teams to maintain high product quality, manage supplier quality, and execute CAPA processes.Key ResponsibilitiesConduct inspections, testing, and audits of products, equipment, and processes to ensure compliance with quality standards and regulatory requirements.Manage and maintain equipment calibration and qualification records, ensuring all equipment is properly validated and ready for use.Oversee supplier quality management, including conducting supplier audits, evaluations, and monitoring supplier performance.Lead and support CAPA processes, including root cause analysis, corrective actions, and preventive measures to address quality issues.Collaborate with the QA Lead and cross-functional teams to maintain and improve the quality management system (QMS).Participate in internal and external audits, supporting documentation and providing evidence of compliance.Review Device History Records (DHR) and other quality documentation related to batch release.Support the development and implementation of quality procedures and SOPsTrain and guide team members on quality standards, procedures, and best practices.Execute CAPA processes to resolve quality issues and implement preventive measures.Perform equipment calibration, qualification, and validation activities.Support internal and external audits and inspections.QualificationsEducation:Bachelor’s Degree in Science (Engineering, Biotechnology, Pharmacy, or a related field)ISO 13485 Certification or equivalent in quality management systemsDesirable: Training in quality control for medical devicesExperience:Minimum of 5 years of experience in quality assurance or quality control within the medical device industry (manufacturing experience preferable)Experience in equipment qualification, calibration, and maintenanceProven experience in supplier quality management, including supplier audits and evaluationsStrong knowledge of Corrective and Preventive Actions (CAPA) processes, root cause analysis, and problem-solving techniquesExperience with batch release processes, inspection requirements, and managing non-conformitiesSkills & Competencies:Fluency in Spanish and English, with excellent communication skills in both languages.Strong attention to detail and commitment to accuracy.Ability to work effectively in a fast-paced, dynamic, and global environment.Exceptional interpersonal skills with the ability to collaborate across departments.Why Join Us?Innovative Environment: Be part of a team that's revolutionizing the IVF process.Growth Opportunities: Contribute to a rapidly growing company with opportunities for career advancement.Global Impact: Work in a dynamic, fast-paced, and global environment.