The Opportunity

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 and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Establish effective Quality Procedures associated to the Quality Management System.
• Manages the Supplier Management process. Ensuring Suppliers are correctly classified based on risk.
• Ensures approved suppliers files follow the established qualification requirements.
• Prepares annual plans for supplier audits and ensures alignment and completion of the established plan.
• Performs or coordinates Supplier audits.

• Leads and facilitates failure investigations, if needed, ensuring mitigations and corrective actions are implemented in a timely manner.
• Monitor Quality systems processes through the performance of periodic metrics.
• Prepared data required for Management Review.
• Responsible for continuous improvement of Quality Systems processes through collection of customer feedback as design transfer activities are occurring.
• Supports Design Transfer activities with Suppliers, coordinates the execution of transfer plans and completes documentation review.
• Manages Supplier Corrective Actions, coordinates resolution of issues and investigations with Suppliers.
• Prepares and reviews Supplier Quality Agreements.
• Participation in the following QMS Systems: Complaint Investigations, Corrective and Preventative Actions, Non-Conforming Material Reports, Supplier and supports audits.
• Collaborate cross-functionally with Assay and Software teams to resolve anomalies identified during the execution of the design and development deliverables. Work in a cross-functional team environment, working with R&D, QA, Software, Operations.
• Know & follow policies & procedures related to work activities performed in area of responsibility.
• Works independently with objectives given by QA Management
• Plans and coordinates own work according to higher-level project schedules.
• Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11

What you'll bring

• Bachelor's degree in Life Sciences or Engineering
• More than 5 years of experiences in a Quality Role
• More than 3 years of experience working with FDA approved class III IVD products.
• Single site PMA experience preferred.
• Working knowledge interpreting and implementing 21CFR820, ISO 13485, ISO 14971 and CLIA
Regulations.

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