Quality Technician II - GMP/QA & CAPA Specialist

Freudenberg Medical LLC; Jeffersonville (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Freudenberg Medical LLC is hiring for a quality-focused role within medical device manufacturing. The position emphasizes applying QMS procedures, GMP principles, and risk management tools to daily tasks and audits.

The candidate will work with CAPA processes, product testing, and regulatory requirements such as ISO 13485 and 21 CFR Part 820, while collaborating with peers to ensure product quality. The role requires about 3+ years of relevant experience, a high school diploma or equivalent

Qualifications

• Candidate must have a high school diploma or equivalent.
• Certification or an associate’s degree is preferred.
• Around 3+ years of relevant experience in medical device manufacturing.
• Experience applying QMS procedures in daily tasks and audits.
• Working knowledge of GMP principles.
• Experience with product testing and inspection methodologies.
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and risk management tools.

Responsibilities

• Maintain procedures and SOPs with intermediate understanding.
• Troubleshoots basic issues.
• Manage consumables and work area.
• Share knowledge with peers.
• Receive guidance and direction.
• Support CAPA investigations and corrective actions.
• Assist with audits and regulatory compliance.
• Contribute to risk management and change control.
• Support training on GMP and QMS.

Skills

QMS procedures

GMP principles

Statistical methods

Education

High school diploma or equivalent

Certification or associate’s degree preferred

Tools

ISO 14971

Six Sigma

DOE

FMEA

CAPA

FDA 21 CFR Part 820

Job description

Freudenberg Medical LLC is hiring for a quality-focused role within medical device manufacturing. The position emphasizes applying QMS procedures, GMP principles, and risk management tools to daily tasks and audits.

The candidate will work with CAPA processes, product testing, and regulatory requirements such as ISO 13485 and 21 CFR Part 820, while collaborating with peers to ensure product quality. The role requires about 3+ years of relevant experience, a high school diploma or equivalent