About our Company:Universal Diagnostics (Universal DX).
is an international Company with a highly experienced team focused on cracking cancer's code.
Through our multi-omics and bioinformatics models, we have figured out how to read the disease's signals in blood with high accuracy to detect cancer in its earliest stages.
Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.The Opportunity:Universal DX is seeking an experienced QA Specialist to join our growing team.
You will work directly the QA Manager and other QA Specialist and will play an integral role in supporting the Quality unit in shaping and executing the Company's Quality strategy to support our growth and expansion in the Life Science space, particularly in the USA and EU.You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers.
As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry.
We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".Why Now?This is an exciting time to be at Universal DX.
We are growing rapidly by building up our team in the EU and the USA.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.How you'll contribute:• Collaborate in the development, review, and maintenance of processes, procedures, and other documents.• Contribute to the development and implementation of Quality policies and procedures in compliance with relevant regulations such as ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 820.• Manage the review and amendment of documents.• Prepare and follow up on document training within the system.• Conduct internal audits of the quality management system.• Promote active participation and staff awareness in the implementation of procedures and other documents within the quality management system.• Assist the QA Manager and the Quality Director in all aspects of the ISO 9001:2015 quality system.• Create and track KPIs/metrics for the Quality Management System and support the preparation of reports for the Quality Directorate.• Maintain and review quality system processes to ensure compliance and drive improvements.• Ensure that the processes necessary for the quality management system are documented, established, implemented, and maintained.• Assist in monitoring Non-Conformities and CAPA issues, ensuring the implementation of actions within established deadlines.• Collaborate on the follow-up and verification of the effectiveness of completed actions.• Provide administrative support for projects and tasks related to quality.• Assist the QA Manager in quality management system audits.• Provide support to staff from other departments on quality matters.• Contribute details for management reviews.What you'll bring:• Master's degree in Quality Management Systems.• Bachelor's degree.• Minimum 2 years of experience as quality consultant or quality specialist.• Good communication skills in English, both spoken and written.• Constancy, effort, patience and perseverance.• Be consistent, committed, competent, responsible and organized.What we´ll offer:• PTO on your Birthday.• Flexible work schedule.• Remote work opportunities.• Flexible Remuneration with our partner Cobee• And more to come….