Lead Manufacturing Quality Engineer – Medical Devices

Kids for the Future; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

NeuWave Medical's Madison, WI facility seeks a Lead Manufacturing Quality Engineer to own manufacturing quality engineering, including process validation, nonconformance management, product release, and equipment qualification for sterile single-use probes and capital consoles.

You will drive MVP reviews, manage NC and CAPA as needed, support audits, and ensure compliance with ISO 13485 and 21 CFR 820, collaborating with cross‑functional teams to maintain a robust QMS.

Qualifications

• 5+ years of quality engineering experience at a medical device manufacturer with 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).

Responsibilities

• Own and maintain the Master Validation Plan (MVP); review IQ/OQ/PQ and 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 NCR Log.
• Convene and chair 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 regulators as needed.

Skills

Quality engineering

Process validation

Audits

Regulatory compliance

Education

Bachelor's degree in Engineering or related field

Tools

ComplianceQuest

ERP systems

Job description

NeuWave Medical's Madison, WI facility seeks a Lead Manufacturing Quality Engineer to own manufacturing quality engineering, including process validation, nonconformance management, product release, and equipment qualification for sterile single-use probes and capital consoles.

You will drive MVP reviews, manage NC and CAPA as needed, support audits, and ensure compliance with ISO 13485 and 21 CFR 820, collaborating with cross‑functional teams to maintain a robust QMS.