Senior Mfg Quality Engineer - Medical Devices

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

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.