Manufacturing Quality Engineer

Manufacturing Quality Engineer

Location: Madison, WI

Work Arrangement: 100% On-Site

Start Date: ASAP

Contract Duration: 6 Months, with Potential for Extension

Pay Rate: $40–$45/hr

Experience Level: Mid-Level to Senior/Lead (5 Years)

Job Overview

We are seeking a highly motivated, hands-on Manufacturing Quality Engineer. This individual will play a critical role in supporting manufacturing operations, ensuring product quality, maintaining regulatory compliance, and driving continuous process improvement.

The ideal candidate will have at least 5 years of manufacturing quality experience, although more senior or lead-level engineers with extensive expertise are encouraged to apply.

This individual will serve as the primary manufacturing quality engineering resource, working closely with manufacturing engineers, production technicians, and cross-functional teams to troubleshoot issues, oversee quality processes, and implement practical, compliant solutions.

This is a 6-month contract opportunity with the potential for extension.

Key Responsibilities

Manufacturing Quality & Process Validation

• Collaborate with manufacturing engineers and production teams to review, guide, and approve process validation plans and execution.
• Review and approve manufacturing process changes, ensuring appropriate qualification and verification activities are completed.
• Partner with production teams to identify quality concerns, troubleshoot manufacturing issues, and implement effective solutions.

Product Release & Quality Compliance

• Manage the final product release process, reviewing batch records and manufacturing documentation for accuracy, completeness, and regulatory compliance.
• Evaluate rejected or nonconforming products and determine appropriate disposition, including rework or scrap.
• Review and approve rework protocols to ensure product quality and compliance standards are maintained.

Root Cause Analysis & Continuous Improvement

• Lead or support root cause investigations related to product defects, manufacturing deviations, and process nonconformances.
• Develop, implement, and verify corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams to improve manufacturing processes, product reliability, and overall quality performance.

Documentation, SOPs & Auditing

• Develop, review, and maintain Standard Operating Procedures (SOPs) and manufacturing quality documentation.
• Guide and mentor team members in creating clear, compliant, and practical procedures.
• Represent the organization during external regulatory audits.
• Participate in and conduct internal quality audits to ensure ongoing compliance.

Required Qualifications

• Minimum of 5 years of experience in manufacturing quality engineering or extensive experience in a related engineering discipline with strong manufacturing quality knowledge.
• Strong understanding of manufacturing quality processes, process validation, product release, CAPA, and root cause investigations.
• Hands-on technical knowledge of mechanical, electrical, and/or software-integrated hardware systems.
• Experience troubleshooting physical products and understanding how hardware components are manufactured, assembled, and integrated.
• Ability to collaborate effectively with manufacturing engineers, production technicians, and cross-functional stakeholders.
• Strong problem-solving, communication, organizational, and documentation skills.
• Practical, solution-oriented mindset with the ability to balance regulatory compliance and operational needs.
• Comfortable working in a fast-paced, evolving startup environment.
• Must be able to work 100% on-site in Madison, Wisconsin, including regular time on the manufacturing floor.
• Valid documentation and ability to travel internationally if future business needs require it. Routine travel is expected to be minimal (less than 10%).

Preferred Qualifications

• Medical device manufacturing experience is highly preferred, particularly with hardware-based medical devices.
• Experience in other highly regulated hardware manufacturing industries, such as aerospace or automotive.
• Familiarity with low-volume, high-complexity manufacturing environments.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.
• Experience supporting regulatory audits, quality management systems, and manufacturing process improvements.

Work Environment & Physical Requirements

• This position requires a fully on-site presence at the Madison, WI facility.
• Work is primarily performed in an office, light-manufacturing, and laboratory environment.
• Regular interaction with manufacturing equipment, hardware, and production personnel is required.
• Must be able to sit or stand for extended periods and operate a computer workstation.
• May occasionally be required to lift up to 25 lbs.