Quality Engineer

Overview

The Quality Engineer is responsible for supporting and improving the current Quality Systems within the Madison, WI manufacturing facility. The position includes tasks such as product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal and external auditing, supplier quality management, and collaboration with Operations, Technical Operations, Engineering, and Materials Management.

• Perform trending and analysis of customer complaint data.
• Drive investigations and manage deviations and NCMRs from initiation to disposition.
• Perform and lead RCAs through cross‑functional team involvement.
• Support development and maintenance of manufacturing quality control processes for new and existing production areas.
• Support supplier quality management with desk audit and quality agreement creation, execution, and review via direct customer contact.
• Maintain PFMEA for new and existing production areas.
• Manage CAPA creation and ensure adequate effectiveness.
• Improve existing procedures to align with cGMP and regulatory requirements.
• Interpret and properly apply all applicable regulatory requirements.
• Improve quality culture through site initiatives.
• Review and approve procedures, protocols, reports, etc., as required.

• Perform internal and external audits of systems and suppliers.
• Filing and management of documentation when required.
• Supporting other Quality System Functions.

• Bachelor’s or higher degree in engineering or applicable science/technology program and 3+ years of experience in a cGMP Quality Assurance/Compliance environment (medical devices preferred).
• OR Associate’s degree with 10+ years of experience in cGMP Quality Assurance (medical devices preferred).
• Effective communication, coaching/mentoring, and presenting skills.
• Ability to manage change.
• Self‑motivated independent and sound decision‑making capabilities.
• Project management skills to deliver on time results.
• Leadership skills / Emotional Intelligence.
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.
• Ability to travel (5-10%).

• Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint.
• Technical writing.
• Statistical analysis - Minitab or other software equivalent, preferred.
• ASQ Certification (preferred).

The Quality Engineer collaborates closely with Manufacturing, Engineering, Quality Control, Facilities, Materials Management, Regulatory Affairs, Maintenance/Metrology, and site external entities such as Distribution Operations, Customer Care, Quality Compliance, etc. The individual must be able to perform in a fast‑paced environment with strict adherence to timelines.

This position reports directly to the Quality Assurance Manager.

Expected during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.

Will mainly work in an office environment but may also be required to work in manufacturing, warehousing, and laboratory areas.

At Keenova, we provide equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions, practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.