Head of Quality & Regulatory Excellence — PMA-Ready

Universal Diagnostics; United States; On-site; USD 220,000 - 300,000; Full time

Benefits offered by this job

22 days PTO with carryover

Equity incentive plan

Holidays + birthday off

Medical, dental, vision + life + long‑

401(k)

Job summary

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

Reporting to the COO, you will lead a multidisciplinary Quality organization of 12 people spanning Design Quality, Document Control, QA, QMS and Supplier Quality, collaborating with Product Development, Laboratory Operations, Manufacturing, Clinical, Medical and

Qualifications

• Bachelor’s degree in life sciences, engineering or a related field; advanced degree preferred.
• 12+ years of progressive quality experience in medical devices, IVDs or molecular diagnostics, with at least 5 years leading managers and multidisciplinary teams.
• Direct quality leadership experience with an FDA Class III IVD PMA or comparable high‑risk diagnostic program; PMA or FDA inspection experience is essential.
• Experience overseeing design controls, requirements traceability, risk management, verification/validation and development across assays, reagents, instruments, automation and software.
• Deep knowledge of FDA QMSR, ISO 13485:2016, ISO 14971, design controls, process validation, supplier controls, CAPA and electronic records.

Responsibilities

• Set and execute the quality strategy, priorities and operating model to support product development, FDA submission, approval and commercialization.
• Ensure a risk‑based QMS that meets 21 CFR Part 820 and ISO 13485:2016 requirements.
• Lead quality activities supporting PMA submission including design controls, risk management, V&V, design transfer and manufacturing readiness.
• Lead and develop a 12‑person quality team with clear responsibilities and succession plans.
• Collaborate cross‑functionally to integrate processes and mandated requirements into development plans and supporting evidence.
• Ensure regulated electronic records are validated and controlled with proper access, workflows and audit trails.
• Oversee core QMS processes: document/change control, nonconformance, CAPA, supplier quality and regulatory reporting.

Skills

Quality leadership

FDA PMA experience

Cross-functional leadership

Risk management

Regulatory knowledge

Quality systems

Education

Bachelor’s degree in life sciences or engineering

Advanced degree preferred

Job description

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

Reporting to the COO, you will lead a multidisciplinary Quality organization of 12 people spanning Design Quality, Document Control, QA, QMS and Supplier Quality, collaborating with Product Development, Laboratory Operations, Manufacturing, Clinical, Medical and