Global Head of Quality & Regulatory Strategy

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

PTO: 22 days + 10 carryover

Equity incentive plan

Company holidays + birthday off

Medical, dental and vision insurance;

401(k) plan

Job summary

Universal DX, Inc. is seeking a Senior Director and Head of Quality to lead the Quality function as we advance colorectal cancer screening tests through analytical and clinical validation, PMA, inspection readiness and commercialization.

Reporting to the COO, you will guide a 12-person quality organization across Design Quality, QA, Document Control and Supplier Quality. You will work with Product Development, Laboratory Operations, Manufacturing, Regulatory and Legal to ensure a robust,

Qualifications

• Bachelor’s degree required; advanced degree preferred in life sciences, engineering, or related field.
• At least 12+ years in quality within medical devices, IVDs, or molecular diagnostics with leadership experience.
• Proven track record with FDA PMA, regulatory submissions, inspections and complex QMS.
• Strong cross-functional leadership and strategic execution skills.

Responsibilities

• Set and execute the quality strategy and operating model for product development and commercialization.
• Lead a 12-person quality organization across Design Quality, QA, Document Control and Supplier Quality.
• Ensure risk-based QMS alignment with FDA 21 CFR Part 820 and ISO 13485:2016.
• Oversee audit and inspection readiness, CAPA, nonconformances and quality metrics.
• Collaborate with Product Development, Manufacturing, Clinical, Regulatory and Legal teams.
• Drive continuous improvement and robust supplier quality oversight.

Skills

Quality leadership

Regulatory knowledge

FDA PMA experience

Cross-functional leadership

Strategic thinking

Education

Bachelor's degree in life sciences or engineering

Advanced degree preferred

Tools

QMS software

ISO 13485:2016

CAPA tooling

Job description

Universal DX, Inc. is seeking a Senior Director and Head of Quality to lead the Quality function as we advance colorectal cancer screening tests through analytical and clinical validation, PMA, inspection readiness and commercialization.

Reporting to the COO, you will guide a 12-person quality organization across Design Quality, QA, Document Control and Supplier Quality. You will work with Product Development, Laboratory Operations, Manufacturing, Regulatory and Legal to ensure a robust,