Senior Quality Engineer: CAPA, DOE & Process Control

Freseniusmedicalcare; Knoxville (TN); On-site; USD 85,000 - 110,000; Full time

Job summary

Fresenius Medical Care in Knoxville, TN, seeks an experienced Engineer with CAPA and quality systems expertise to coordinate investigations and support design control from concept through release. You will apply statistical methods (DOE, R&R) and lead root-cause analyses, ensure regulatory compliance, and mentor staff in CAPA processes within a manufacturing environment.

Strong communication and documentation skills, plus the ability to read and interpret complex technical reports, are essential

Qualifications

• Bachelor's degree in a related field required.
• 5–8 years of related experience; or a Master’s degree with 3 years experience.
• Strong analytical & troubleshooting skills.
• Ability to understand and employ mathematics at an engineering or scientific level.
• Strong technical report writing skills.
• Experience with CAPA, NCR, MCH, and related quality processes.

Responsibilities

• Coordinate timely and complete investigations within the assigned manufacturing plant.
• Ensure compliance to all state and Federal regulations and requirements.
• Compose and execute design and process verification and validation protocols and reports.
• Investigate root cause solutions for product release through NCR, CAPA, and MCH.

Skills

Analytical & troubleshooting

Mathematical ability

Technical report writing

Effective communication

Microsoft Office

Education

Bachelor's Degree

Advanced Degree desirable

Tools

Excel

DOE

Gage R&R

Statistical Analysis

Job description

Fresenius Medical Care in Knoxville, TN, seeks an experienced Engineer with CAPA and quality systems expertise to coordinate investigations and support design control from concept through release. You will apply statistical methods (DOE, R&R) and lead root-cause analyses, ensure regulatory compliance, and mentor staff in CAPA processes within a manufacturing environment.

Strong communication and documentation skills, plus the ability to read and interpret complex technical reports, are essential