Quality Systems Specialist — CAPA & Audit Lead

Kids for the Future; Madison (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

NeuWave Medical in Madison, WI, is hiring a Quality System Specialist to support the Quality System Manager. This role focuses on document lifecycle, CAPA management, and maintaining ISO 13485, MDSAP, and regulatory readiness.

Responsibilities include preparing procedures, leading internal audits, coordinating external audits, and driving continuous improvement of QMS processes in a manufacturing environment.

Qualifications

• Bachelor's degree in a technical, scientific, or quality-related field.
• 3–5 years of quality assurance experience at a medical device manufacturer.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Demonstrated experience with document control, CAPA, or internal audit processes.
• Proficient with standard office software (Microsoft Office suite or equivalent).

Responsibilities

• Prepare, review, and approve quality system documents (procedures, work instructions, forms) for accuracy, compliance, and consistency prior to release.
• Administer the CAPA program — review and route CAPA records, verify root cause analysis and corrective/preventive action plans are documented, track action items to closure, and confirm effectiveness checks are completed and recorded.
• Trend CAPA and audit data for review at quality system management reviews.
• Support certification-maintenance activities for ISO 13485, MDSAP, and MDD/MDR certifications, including gathering evidence and timelines.
• Support planning and execution of the internal audit program — scheduling audits, preparing checklists, participating in audits, documenting findings, and tracking actions.
• Support preparation for external audits (Notified Body/Registrar, FDA), including hosting auditors and coordinating evidence retrieval.
• Assist inputs for management reviews, including data on objectives, audit results, CAPA trends, and post-market surveillance.
• Partner with the Quality System Manager on continuous improvement of QMS processes.

Job description

NeuWave Medical in Madison, WI, is hiring a Quality System Specialist to support the Quality System Manager. This role focuses on document lifecycle, CAPA management, and maintaining ISO 13485, MDSAP, and regulatory readiness.

Responsibilities include preparing procedures, leading internal audits, coordinating external audits, and driving continuous improvement of QMS processes in a manufacturing environment.