Senior Manufacturing Quality Engineer - On-site Madison

Medasource; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Medasource in Madison, WI seeks a Manufacturing Quality Engineer to ensure quality, compliance, and process safety on-site. The role collaborates with manufacturing and production teams to uphold standards.

We target a mid-level candidate with 5+ years of experience, but will consider a more senior or lead-level engineer with deep fluency in manufacturing quality. This is a full-time, direct-hire role on the production floor.

Qualifications

• Minimum of 5 years of experience in manufacturing quality or related engineering with deep QA responsibilities.
• On-site presence in Madison, Wisconsin, with hands-on work on the production floor.
• Strong mechanical, electrical, or software hardware literacy for troubleshooting physical products.
• Pragmatic, collaborative problem solver able to work with cross-functional teams.
• Willingness to travel internationally if required in the future.

Responsibilities

• Process validations: review, guide, and approve validation plans and execution.
• Final product release: own release process and review batch records for regulatory compliance.
• Process change management: approve changes with robust qualification activities.
• Product disposition & rework: determine rework feasibility and manage scrap procedures.
• CAPA & root-cause investigations: lead or assist investigations and verify corrective actions.
• SOPs & documentation: author SOPs and mentor teammates in compliant procedures.
• Auditing & compliance: partake in external audits and internal quality audits.

Skills

Manufacturing quality

Process validation

CAPA investigations

Cross-functional collaboration

Troubleshooting hardware

Job description

Medasource in Madison, WI seeks a Manufacturing Quality Engineer to ensure quality, compliance, and process safety on-site. The role collaborates with manufacturing and production teams to uphold standards.

We target a mid-level candidate with 5+ years of experience, but will consider a more senior or lead-level engineer with deep fluency in manufacturing quality. This is a full-time, direct-hire role on the production floor.