Senior Quality Engineer - Medical Devices & CAPA Leader

Freudenberg; Jeffersonville (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Freudenberg is seeking a Quality Engineer to advance medical device quality systems in Indiana. You will apply FDA QSR (21 CFR 820), ISO 13485, and EU MDR, lead CAPA investigations, perform root cause analyses, and drive process validation and manufacturing controls.

You'll collaborate with Manufacturing, Engineering, and Operations to address nonconformances and support audits. The role emphasizes quality data analysis, risk management, and design control familiarity, with opportunities to

Qualifications

• 3–5+ years in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems.
• Experience with nonconformance management, CAPA, root cause analysis, and product quality.
• Strong working knowledge of medical device quality and regulatory requirements, including FDA Quality System requirements ISO 13485 EU MDR GMP.
• Experience leading CAPA activities and root cause investigations.
• 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 and preventive actions.
• Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.

Responsibilities

• Advanced understanding of procedures and equipment.
• Resolves most issues independently.
• Prioritizes tasks and supports training.
• Leads by example and formally trains junior staff or acts as a resource for colleagues with less experience.
• Proficient in applying FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
• Strong understanding of GMP principles and quality assurance practices.
• Skilled in product testing, inspection, and statistical quality control.
• Proficient in risk management methodologies and post-market surveillance.
• Ability to lead CAPA investigations and implement sustainable corrective actions.
• Familiarity with design control processes to ensure compliance with performance criteria.
• Participation in internal and external audits.

Skills

CAPA investigations

Root cause analysis

Nonconformance mgmt

Regulatory knowledge

Quality data analysis

Process validation

Change control

Cross-functional collaboration

Software validation

Education

Bachelor’s degree in Engineering/Quality/Biomedical Engineering

Job description

Freudenberg is seeking a Quality Engineer to advance medical device quality systems in Indiana. You will apply FDA QSR (21 CFR 820), ISO 13485, and EU MDR, lead CAPA investigations, perform root cause analyses, and drive process validation and manufacturing controls.

You'll collaborate with Manufacturing, Engineering, and Operations to address nonconformances and support audits. The role emphasizes quality data analysis, risk management, and design control familiarity, with opportunities to