Quality Technician II

Freudenberg Group•Jeffersonville, IN

About The Position

This role involves an intermediate understanding of procedures, troubleshooting basic issues, managing consumables and work areas, and sharing knowledge with peers. The Quality Technician II receives a moderate level of guidance and direction. Key responsibilities include applying QMS procedures in daily tasks and audits, utilizing working knowledge of GMP principles in medical device manufacturing, and proficiency in product testing and inspection methodologies. The role also requires practical use of statistical methods, process control, and quality tools such as Six Sigma, DOE, and FMEA. Experience with risk management documentation (e.g., ISO 14971) for risk mitigation and change management, active participation in CAPA investigations, and implementation of corrective/preventive actions are essential. The position also involves learning FDA regulations (21 CFR Part 820) and ISO 13485 standards.

Requirements

High school diploma or equivalent.
~3+ years relevant experience.

Nice To Haves

Certification or associate’s degree preferred.

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.