Remote Principal Quality Engineer, Medical Devices

FloodGate Medical; Atlanta (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

FloodGate Medical is seeking a Principal Quality Engineer to lead Design Controls, risk management, and CAPA in a fast-moving, startup-like medical device environment. The role focuses on owning quality systems rather than executing token tasks, with a patient-centric approach and rapid iteration to support devices advancing toward FDA review.

You will influence the QMS development and quality strategy at a company delivering remote cardiac monitoring solutions to a growing patient population.

Qualifications

• Experience with Design Controls and Risk Management in medical devices.
• Ownership of CAPA processes and continuous improvement in QMS.
• Experience shaping or overhauling a QMS in startup or high-growth medical devices.

Skills

Design Controls

Risk Management

CAPA

Quality Engineering

Job description

FloodGate Medical is seeking a Principal Quality Engineer to lead Design Controls, risk management, and CAPA in a fast-moving, startup-like medical device environment. The role focuses on owning quality systems rather than executing token tasks, with a patient-centric approach and rapid iteration to support devices advancing toward FDA review.

You will influence the QMS development and quality strategy at a company delivering remote cardiac monitoring solutions to a growing patient population.