The Opportunity:

Universal DX is seeking a Senior Quality Engineer of Design Quality to join our Quality team. In this role, you will ensure that our assay and software systems meet rigorous quality and regulatory standards by reviewing protocols, identifying and resolving anomalies, and maintaining compliance with FDA QSR, ISO 13485, ISO 14971, and 21 CFR Part 11. You’ll collaborate cross-functionally to support continuous improvement and ensure timely execution of quality deliverables.

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”.

How you’ll contribute:

• Review software or assay protocols and reports to ensure all changes are verified, and assay or software system is adequately validated in accordance with design controls and Quality System Requirements.
• Proactively communicate variances and anomalies identified during the review process to Quality Management.
• Resolve minor protocol variances through collaboration with proper SMEs to ensure compliance and resolution.
• Collaborate cross-functionally with Assay and Software teams to resolve anomalies identified during the execution of the design and development deliverables.
• Identify and update SOP and Forms to ensure continuous compliance to the QMS and regulatory requirements.
• Must align to project timelines and complete review and approvals on time.
• Assist 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
• Know & follow policies & procedures related to work activities performed in area of responsibility.
• Work independently with objectives given by QA Management
• Plan and coordinate own work according to higher-level project schedules.
• Complete quality tasks in accordance with current Quality System Requirements.
• Follow all functions and responsibilities associated to this position that are described in UDX documents.

What you’ll bring:

• Bachelor’s degree in Life Sciences or Engineering or a related field
• More than 5 years of experiences in a Quality Role, OR an equivalent combination of education, training, and/or experience.
• More than 3 years of experience working with FDA approved, OR an equivalent combination of education, training, and/or experience.
• Single site PMA experience preferred.
• Working knowledge interpreting and implementing 21CFR820, ISO 13485, ISO 14971 and CLIA regulations.

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

• Flexible work schedule

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k)

• And more to come...