Quality Technician II

Freudenberg; Jeffersonville, Northern (IN, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Freudenberg is hiring a Quality Technician II in Jeffersonville, IN to support inspection, testing, and QA documentation in a medical device environment. You will apply QMS procedures, perform product testing, and assist in CAPA investigations while following GMP and regulatory guidelines.

The role requires ~3+ years of relevant experience, an equivalent HS diploma, and knowledge of ISO 13485 and FDA 21 CFR 820. On-site position with collaborative team setup.

Qualifications

• High school diploma or equivalent required; certification/assoc degree preferred.
• ~3+ years relevant experience in medical device manufacturing preferred.
• Experience applying QMS procedures and audits, with GMP knowledge.

Responsibilities

• Support inspection, testing, and document control activities.
• Assist CAPA investigations and implement corrective actions.
• Apply ISO 13485 and FDA 21 CFR 820 knowledge in daily tasks.
• Contribute to risk management and change control processes.

Skills

Troubleshooting

QMS procedures

Statistical methods

CAPA investigations

Risk management

GMP knowledge

Product testing

FDA CFR 820 knowledge

ISO 13485 knowledge

Education

High school diploma or equivalent

Certification or associate’s degree preferred

Tools

Six Sigma

DOE

FMEA

Job description

## Quality Technician IIApply: Jeffersonville, IN: Full time: Posted Today: R\\_00106282**Working at Freudenberg: We will wow your world!**# 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 (e.g., Six Sigma, DOE, FMEA).* Experience using risk management documentation (e.g., 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.# Qualifications:* High school diploma or equivalent.* Certification or associate’s degree preferred.* ~3+ years relevant experience. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.Freudenberg Medical LLC