Quality Systems Specialist - CAPA & Audit Lead

NeuWave Medical Inc.; Madison (WI); On-site; USD 70,000 - 95,000; Full time

Job summary

NeuWave Medical, based in Madison, WI, seeks a Quality System Specialist to support the Quality System Manager in maintaining and improving the Quality Management System. You will handle document lifecycle management, CAPA administration, and support audits and management reviews.

The role emphasizes ensuring ISO 13485 compliance, 21 CFR 820 alignment, and collaboration across QA, manufacturing, and regulatory functions to drive continuous improvement and ensure readiness for internal and

Qualifications

• IJE major requirements: Bachelor's degree in a technical, scientific, or quality-related field.

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, preparing documentation packages, and tracking timelines.
• Support planning and execution of the internal audit program - scheduling audits, preparing audit checklists, participating in or leading internal audits, documenting findings, and tracking corrective actions to closure.
• Support preparation for and execution of external audits (Notified Body/Registrar, FDA), including hosting auditors and coordinating evidence retrieval.
• Support inputs for quality system management reviews, including data on objectives, audit results, CAPA/PA trends, and post-market surveillance.
• Partner with the Quality System Manager on continuous improvement of QMS processes.

Skills

Quality Assurance

Documentation Control

CAPA

Audit

ISO 13485

21 CFR 820

MS Office

Education

Bachelors degree in technical/scientific/quality-related field

Tools

ComplianceQuest

Job description

NeuWave Medical, based in Madison, WI, seeks a Quality System Specialist to support the Quality System Manager in maintaining and improving the Quality Management System. You will handle document lifecycle management, CAPA administration, and support audits and management reviews.

The role emphasizes ensuring ISO 13485 compliance, 21 CFR 820 alignment, and collaboration across QA, manufacturing, and regulatory functions to drive continuous improvement and ensure readiness for internal and