Lead Manufacturing Quality Engineer

NeuWave Medical Inc.; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

NeuWave Medical Inc. in Madison, WI seeks a Lead Manufacturing Quality Engineer to own manufacturing quality engineering, including process validation, nonconformance management, product release, and equipment qualification, ensuring sterile single-use probes and capital consoles meet the QMS.

You will lead validation activities (IQ/OQ/PQ, TMV), manage NCRs, chair MRB reviews, assess CAPA escalation, and support audits with regulatory bodies and Notified Bodies as needed.

Qualifications

• Bachelor's degree in Engineering or related field (or equivalent).
• 5+ years of quality engineering experience at a medical device manufacturer, 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 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; evaluate revalidation on change.
• Coordinate nonconforming product reviews; maintain NCR Log and MRB disposition reviews.
• Chair MRB reviews; approve rework instructions and post-rework verification.
• Determine if nonconformances require escalation to CAPA and manage releases of finished devices.
• Support equipment qualification and calibration programs; assist audits and regulatory inspections.

Skills

Quality engineering

Manufacturing quality

Process validation

Audits

CAPA

Education

Bachelor's degree in Engineering or related technical field

Tools

ERP systems (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.