Quality
USA - Remote
Type of employment
Full-Time
GROSS ANNUAL SALARY
Based on experience
Probation period
6 months
Annual Bonus
Up to 20% gross salary
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".
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.
• 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
• 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.
By being part of the team, you will be in a company that wants more than to become one of theleaders in the industry. We want to have a huge positive impact on society by achieving theambitious purpose of “making cancer a curable disease by detecting it earlier”.
Type of employment
Full-Time
GROSS ANNUAL SALARY
Based on experience
Probation period
6 months
Annual Bonus
Up to 20% gross salary
Flexible work schedule
Remote work opportunities
Free day on your birthday
Parking incentive on office locations
Free cafe amenities on office locations
Possibility to buy extra vacation days
Optional health insurance plan
And more
Those who thrive at Universal Diagnostics prioritize, manage, and execute their own goals with ownership. They embrace working in collaborative mode in a multi-cultural and multi- disciplinary environment that allows to learn from others as well as share one’s own knowledge. They welcome and provide constructive feedback and criticism, trusting in the good intentions of others, and being secure in the knowledge that embracing mistakes is the best way to learn and grow. This position is meant for people who are driven by the opportunity to see their work having impact in the global fight against cancer.