Director of Quality

Director of Quality NeuWave Medical, Inc - 3.5 Madison, WI Job Details Full-time 1 day ago Benefits Relocation assistance Qualifications Cross-functional collaboration Full Job Description About NeuWave NeuWave Medical develops image guided microwave ablation tools and software that enables physicians to treat tumors in a minimally invasive procedure. This technology allows patients to be treated in outpatient settings, reducing procedural complexity and recovery times. Our organization is excited to be embarking on numerous new development projects to further improve patient care, and we are looking for new teammates to help us on this inspired journey. You'll join an interdisciplinary group of engineers who work closely with manufacturing, quality, regulatory, clinical, and strategic marketing professionals. This team highly values rapid experimentation and close collaboration with clinicians. Our culture blends friendly competition with genuine camaraderie—we move quickly, celebrate wins, and build lasting relationships while shaping the future of the business. As part of NeuWave, you'll have access to a comprehensive offering of competitive benefits. If you're motivated by clinically meaningful problems, evidence driven development and building solutions at scale, NeuWave offers the chance to perform career defining work-with freedom to develop yourself within a progressive and growing healthcare company. Position Summary NeuWave is seeking a dynamic Associate Director of Quality Assurance to lead and scale our quality function during a critical phase of transition and innovation. This role is responsible for establishing and maintaining compliant quality systems (ISO 13485, 21 CFR 820), leading audits, ensuring product safety, and partnering cross-functionally with R D and Operations. The Associate Director will drive a strong quality culture while overseeing full-time and contract staff across New Product Development & Lifecycle Quality, Quality Systems, Production & Service Quality, Supplier Quality, and Post-Market Surveillance. A key focus will be leading major transition initiatives, including standing up a new Quality System, implementing a new eQMS, and executing the 2026 functional business plan. Key Accountabilities Lead and maintain a compliant Quality Management System (QMS) aligned with

FDA, ISO 13485, EU

MDR, and global regulatory standards; drive achievement of key quality metrics, including CAPA effectiveness. Oversee major transition initiatives, including implementation of a new QMS, eQMS deployment and validation, and migration of legacy quality systems. Ensure audit readiness and lead internal, third-party, and regulatory audits, including TÜV surveillance audits. Oversee product and lifecycle quality, including risk management, design controls, production quality, and post-market surveillance. Strengthen supplier quality and manufacturing performance, driving operational efficiency and Cost of Goods (COGs) improvements. Build and lead a high-performing Quality team while advancing a strong, business-aligned quality culture.

Education, Experience & Skills Education:

Bachelor's degree in Engineering, Science, or related field required; advanced degree preferred.

Experience:

5+ years in Quality within regulated industries, including leadership experience.

Leadership:

Proven ability to lead cross-functional quality teams across production, systems, and post-market activities. Location This position will be based in Madison, Wi. Relocation assistance may be available for the preferred candidate. Equal Opportunity Employer NeuWave Medical is an equal opportunity employer. We are committed to creating an inclusive environment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.