Senior Quality Engineer – CAPA & Process Excellence

Fresenius Medical Care; Knoxville (TN); On-site; USD 85,000 - 130,000; Full time

Job summary

Fresenius Medical Care seeks an Engineer with a CAPA focus to manage analysis of quality data and CAPA investigations across the plant. You will guide CAPA procedures, coordinate investigations, and mentor staff to ensure regulatory compliance.

Responsibilities include leading audits, maintaining CAPA files, and driving continuous improvement in quality systems while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in a relevant field required.
• 5–8 years of related experience; or a Master's degree with 3 years' experience.

Responsibilities

• Coordinate timely and complete CAPA investigations within the plant.
• Lead analysis of CAPA trends and plant quality data.
• Maintain CAPA files and ensure regulatory compliance.
• Provide direction to staff on CAPA responsibilities and training.
• Lead and participate in internal and external audits as required.

Skills

Analytical skills

Troubleshooting

Technical report writing

MS Office

Communication skills

Reading & interpretation

Gage R&R

DOE

Correlation & regression

Acceptance sampling

Education

Bachelor's degree

Advanced degree desirable

Job description

Fresenius Medical Care seeks an Engineer with a CAPA focus to manage analysis of quality data and CAPA investigations across the plant. You will guide CAPA procedures, coordinate investigations, and mentor staff to ensure regulatory compliance.

Responsibilities include leading audits, maintaining CAPA files, and driving continuous improvement in quality systems while collaborating with cross-functional teams.