Senior Quality Engineer - Medical Devices, CAPA Lead

Freudenberg Group; Jeffersonville (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Freudenberg Group in Indiana seeks a Quality Engineer/Quality Systems professional with 3–5+ years in the medical device sector. You will apply FDA QSR, ISO 13485, EU MDR and GMP knowledge to drive CAPA, nonconformances, change control, and process validation across manufacturing teams.

You will lead investigations, analyze quality data, and collaborate with Manufacturing, Engineering, and Operations to ensure product quality and regulatory compliance throughout the product lifecycle.

Qualifications

• 3–5+ years in the medical device industry, incl. at least 3 years in Quality Engineering or Quality Systems.
• Proven experience with nonconformance management, CAPA, root cause analysis, and product quality.
• Experience in a regulated manufacturing environment.
• Strong knowledge of FDA Quality System requirements, ISO 13485, EU MDR, GMP.
• Understanding of quality system requirements and industry best practices.
• Experience managing and investigating nonconformances and leading CAPA activities.
• Experience with process validation and manufacturing process controls.
• Experience with change control and change management.
• Experience with software validation, as applicable.
• Ability to analyze quality data, identify trends, and drive corrective/preventive actions.
• Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.

Responsibilities

• Apply procedures and equipment understanding to ensure compliant manufacturing.
• Lead CAPA investigations and implement corrective actions.
• Train and mentor junior staff, act as a resource for colleagues.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and GMP.
• Support design control and design transfer activities.
• Participate in internal and external audits.
• Perform product testing, inspection, and statistical quality control.
• Identify quality data trends and drive improvements across processes.

Skills

Quality engineering

CAPA

Root cause analysis

Nonconformance management

Process validation

Change control

Software validation

Quality data analysis

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or related field

Job description

Freudenberg Group in Indiana seeks a Quality Engineer/Quality Systems professional with 3–5+ years in the medical device sector. You will apply FDA QSR, ISO 13485, EU MDR and GMP knowledge to drive CAPA, nonconformances, change control, and process validation across manufacturing teams.

You will lead investigations, analyze quality data, and collaborate with Manufacturing, Engineering, and Operations to ensure product quality and regulatory compliance throughout the product lifecycle.