Quality System Specialis

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

Position Summary

The Quality System Specialist supports the Quality System Manager in maintaining and continuously improving NeuWave Medical's Quality Management System, with responsibility for quality document lifecycle management, CAPA administration, certification-maintenance activities, and audit and management review support.

Brief Description

The Quality System Specialist supports the Quality System Manager in maintaining and continuously improving NeuWave Medical's Quality Management System, with responsibility for quality document lifecycle management, CAPA administration, certification-maintenance activities, and audit and management review support.

Key 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 NeuWave's ISO 13485, MDSAP, and MDD/MDR certifications, including gathering evidence, preparing documentation packages, and tracking certification and recertification 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 preparation of inputs for quality system management reviews, including compiling data on quality objectives, audit results, CAPA/PA trends, and complaint/post-market surveillance data.
• Partner with the Quality System Manager on continuous improvement of QMS processes.

Required 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).

Preferred Qualifications

• ASQ certification (CQA or CQE).
• ISO 13485 Lead/Internal Auditor certification.
• Experience with EU MDR requirements and MDSAP.
• Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections is a plus.
• Experience with ERP systems and eQMS platforms, specifically ComplianceQuest, is a plus.

Travel Requirements

Less than 10%.

Work Environment & Physical Demands

Work is primarily performed in an office and light-manufacturing/lab environment at NeuWave Medical's Madison, WI facility. Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.

Equal Employment Opportunity

NeuWave Medical (a Precision IO Group company) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other status protected by applicable law.