Quality Technician II

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

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 Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.