.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
- Supporting the QA Manager and Quality Director in all aspects of the quality system.
- Maintaining and reviewing the quality system processes to ensure compliance and improvements to the system.
- Helping in the development and implementation of Quality policies and procedures in compliance with applicable regulations such as ISO 9001:2015, ISO 13485:2016 and FDA 21 CFR Part 820.
- Supporting QA Manager to draft, disseminate and enforce quality policy and proposed objectives.
- Assisting in the development, review, and maintenance of processes, procedures, and other documents.
- Supporting QA Manager to promote the active participation and awareness of all personnel in the implementation of all procedures.
- Supporting QA Manager to ensure that processes needed for the quality management system are documented, established, implemented, and maintained.
- Monitoring Non-Conformities and CAPA issues and ensure the actions are implemented within agreed timeframes.
- Following up verification and effectiveness of actions completed.
- Providing administration assistance with all quality related projects and duties.
- Maintaining and controlling document reviews and amendments.
- Assisting the QA Manager on QMS audits.
- Helping personnel from other departments on quality issues.
- Providing input details for management reviews.
- Supporting inter-departmental training initiatives.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 will offerBy being part of the team, you will be in a company that wants 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"
