Principal Quality Engineer- Georgia

About Zywie

Founded in 2014, Zywie is a founder-led, privately held remote cardiac monitoring company on a mission to transform cardiovascular care. Our flagship product, the ZywieNano™ MCT Patch — the smallest cardiac monitoring patch on the market — delivers up to 30 days of continuous ECG monitoring paired with ZywieAI™, our proprietary AI-driven arrhythmia detection platform.

We have monitored over 500,000 patients, analyzed more than 1 trillion heartbeats, and generated 4.5 million unique clinical notifications. We are profitable, self-funded, and scaling fast — growing our commercial team from 3 to nearly 25 reps in five years. We are now entering the most exciting chapter of our growth: developing and bringing our own proprietary hardware to market. That's where you come in.

The Opportunity

As we transition from a software and services company to a full medical device manufacturer, we're building our Quality organization from the ground up — and we need a Principal Quality Engineer to lead that build. Our first proprietary hardware device is already in active FDA 510(k) submission, with three more devices behind it in our R&D pipeline. This is a foundational, highly visible role: you'll design, implement, and scale our Quality Management System while directly supporting the development and commercialization of our hardware portfolio, reporting to our Sr. Director, Quality & Regulatory Affairs.

What You'll Do

• 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

What You'll Bring

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

Compensation & Benefits

• Competitive base salary plus performance bonus, commensurate with experience
• 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 when the right person is identified