Quality Technician II | GMP & CAPA Investigator

Freudenberg Group; Jeffersonville (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Freudenberg Group is seeking a quality-focused professional to support medical device manufacturing. The role emphasizes adherence to QMS and GMP requirements, with hands-on testing, risk management, and CAPA activities to ensure compliant product quality.

Ideal candidates will have 3+ years of relevant experience, a high school diploma or higher, and be prepared to work in a structured, regulated environment in Indiana. Employment is full-time with opportunities for growth.

Qualifications

• Background applying QMS procedures in daily tasks and audits.
• Working knowledge of GMP principles in medical device manufacturing.
• Experience with product testing and inspection methodologies.
• Familiarity with risk management (ISO 14971) and CAPA processes.

Responsibilities

• Intermediate understanding of procedures.
• Troubleshoots basic issues.
• Manages consumables and work area.
• Shares knowledge with peers.
• Receives a moderate level of guidance and direction.
• Experience applying QMS procedures in daily tasks and audits.
• Working knowledge of GMP principles in medical device manufacturing.
• Proficient in product testing and inspection methodologies.
• Practical use of statistical methods, process control, and quality tools (Six Sigma, DOE, FMEA).
• Experience using risk management documentation (ISO 14971) for risk mitigation and change management.
• Active participation in CAPA investigations and implementation of corrective/preventive actions.
• Learning FDA regulations (21 CFR Part 820) and ISO 13485 standards.

Skills

Quality Assurance

GMP knowledge

CAPA investigations

Statistical methods

Process control

FMEA

Education

High school diploma or equivalent

Certification or associate’s degree

Job description

Freudenberg Group is seeking a quality-focused professional to support medical device manufacturing. The role emphasizes adherence to QMS and GMP requirements, with hands-on testing, risk management, and CAPA activities to ensure compliant product quality.

Ideal candidates will have 3+ years of relevant experience, a high school diploma or higher, and be prepared to work in a structured, regulated environment in Indiana. Employment is full-time with opportunities for growth.