Quality Technician II: Medical Devices GMP/QA

Freudenberg Medical, LLC; Jeffersonville (IN); On-site; USD 52,000 - 66,000; Full time

Benefits offered by this job

401K Match

Diversity & Inclusion

Safe Environment

Personal Development

Corporate Events

Job summary

Freudenberg Medical LLC in Jeffersonville, IN is seeking a Quality Technician II to support our on-site quality systems. You will apply GMP and QMS procedures in daily tasks, troubleshoot issues, manage consumables and the work area, and share knowledge with peers.

You will participate in CAPA investigations, work with ISO 13485 and FDA 21 CFR Part 820, and use statistical methods and quality tools to drive risk mitigation and product testing improvements.

Qualifications

• High school diploma or equivalent (required).
• Certification or associate’s degree preferred.
• ~3+ years relevant experience in medical device manufacturing quality.

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.

Skills

QMS procedures

GMP principles

CAPA investigations

FDA 21 CFR Part 820

ISO 13485

Statistical methods

Product testing

Risk management

Six Sigma/DOE

Process control

Documentation & traceability

Share knowledge with peers

Education

High school diploma or equivalent

Certification or associate’s degree preferred

Job description

Freudenberg Medical LLC in Jeffersonville, IN is seeking a Quality Technician II to support our on-site quality systems. You will apply GMP and QMS procedures in daily tasks, troubleshoot issues, manage consumables and the work area, and share knowledge with peers.

You will participate in CAPA investigations, work with ISO 13485 and FDA 21 CFR Part 820, and use statistical methods and quality tools to drive risk mitigation and product testing improvements.