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
Zywie is an Equal Opportunity Employer. Zywie does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.