Principal Quality Engineer- Georgia

FloodGate Medical • Tampa, FL

4d • Remote

About The Position

Zywie, a founder-led, privately held remote cardiac monitoring company, is seeking a Principal Quality Engineer to build its Quality organization from the ground up. As Zywie transitions to a full medical device manufacturer, this role will be instrumental in designing, implementing, and scaling the Quality Management System (QMS) to support the development and commercialization of its hardware portfolio. The company's first proprietary hardware device is already in active FDA 510(k) submission, with more devices in the R&D pipeline. This is a foundational, highly visible role reporting to the Sr. Director, Quality & Regulatory Affairs.

Requirements

• Bachelor's degree in Engineering or a related technical discipline; Master's preferred
• 5+ years of Quality Engineering experience in the medical device industry
• Demonstrated experience building or significantly enhancing a Quality Management System — not just operating within one
• Deep knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and IEC 62304
• Experience supporting Class II and/or Class III medical devices
• Experience supporting FDA inspections and ISO certification audits
• Strong Design Controls and Risk Management expertise
• Experience implementing electronic Quality Management Systems
• Excellent communication and leadership skills

Nice To Haves

• Experience in startup or high-growth medical device companies
• Experience supporting software-enabled devices (SaMD/SiMD), including AI/ML-enabled devices
• ASQ Certified Quality Engineer (CQE), CQA, or equivalent certification

Responsibilities

• Design, implement, and maintain an ISO 13485 and FDA 21 CFR Part 820/QMSR compliant Quality Management System
• Lead Design Control activities across the product lifecycle, including Design Inputs, Outputs, Verification, Validation, and Design Reviews
• Lead ISO 14971 Risk Management processes — hazard analysis, FMEA, benefit-risk analysis, and risk management reporting
• Support software development teams to ensure compliance with IEC 62304, and review software lifecycle and verification documentation
• Build and manage our supplier quality program, including audits and qualification for our contract manufacturer
• Lead CAPA, nonconformance, change control, and complaint handling processes
• Support process validation, manufacturing readiness, and Design Transfer activities
• Lead implementation and validation of our electronic Quality Management System (eQMS)
• Prepare the organization for FDA inspections and ISO 13485 certification, including all supporting documentation
• Partner cross-functionally with Engineering, Clinical, Operations, Regulatory Affairs, and Manufacturing
• Mentor future Quality Engineers as our organization grows

Benefits

• Competitive base salary plus performance bonus
• Full travel reimbursement — flight, hotel, transportation, and daily meal stipend for Atlanta office visits
• Health Insurance
• PTO and Holidays
• 401(k) with company match
• Life Insurance & AD&D Insurance
• Direct access to senior leadership and the opportunity to build something that matters
• A lean, entrepreneurial culture that rewards results and moves fast

What This Job Offers

• Job Type: Full-time
• Career Level: Principal