Lead Manufacturing Quality Engineer

NeuWave Medical Inc.; Madison (WI); On-site; USD 90,000 - 140,000; Full time

Job summary

NeuWave Medical Inc. in Madison, WI, seeks a Lead Manufacturing Quality Engineer to own the manufacturing quality program for sterile single-use probes and capital consoles.

You will oversee process validation, nonconformance handling, product release, and equipment qualification in a GMP environment. Candidates bring 5+ years in medical device quality engineering, ISO 13485/21 CFR 820 knowledge, and strong audit experience.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years of quality engineering experience in medical devices.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Experience leading internal and external quality audits.

Responsibilities

• Own and manage Master Validation Plan (MVP) and IQ/OQ/PQ protocols.
• Document validation status before production use; assess revalidation needs after changes.
• Lead NCRs, coordinate MRB reviews, and approve dispositions.
• Approve release of finished devices; support equipment qualification and calibration.
• Support audits and host regulatory/notified body auditors as needed.

Skills

Quality engineering

Medical device manufacturing

Audits

MS Office

Education

Bachelor's degree in Engineering

Tools

ERP systems

eQMS ComplianceQuest

Job description

The Lead Manufacturing Quality Engineer owns manufacturing quality engineering for NeuWave Medical's Madison operations, including process validation, nonconformance management, product release, and equipment qualification, ensuring sterile single-use probes and capital consoles are manufactured in compliance with the QMS.

Key Responsibilities

• Own and maintain the Master Validation Plan (MVP); review and approve IQ/OQ/PQ and Test Method Validation (TMV) protocols and reports.
• Confirm validation status is documented prior to use of equipment or processes in production, and evaluate revalidation requirements upon change.
• Coordinate identification, review, investigation, and disposition of nonconforming product and process nonconformances; maintain the Nonconformance Report (NCR) Log.
• Convene and chair Material Review Board (MRB) disposition reviews; review and approve rework instructions and confirm post-rework verification is completed prior to release.
• Determine and document whether nonconformances require escalation to CAPA.
• Approve release of finished devices per established quality procedures; support equipment qualification and calibration programs.
• Support internal and external audits related to manufacturing quality, including hosting regulatory and Notified Body auditors as needed.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field (or equivalent combination of education and experience).
• 5+ years of quality engineering experience at a medical device manufacturer, with a focus on manufacturing/process quality.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Demonstrated experience with internal and/or external quality audits.
• Proficient with standard office software (Microsoft Office suite or equivalent).

Preferred Qualifications

• ASQ certification (CQE, CRE, or equivalent).
• 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.

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.