Quality Technician II

Freudenberg•Jeffersonville, IN

40d•Onsite

About The Position

This role involves an intermediate understanding of procedures, troubleshooting basic issues, managing consumables and work area, and sharing knowledge with peers. The individual receives a moderate level of guidance and direction. The position requires experience applying QMS procedures in daily tasks and audits, working knowledge of GMP principles in medical device manufacturing, proficiency in product testing and inspection methodologies, and 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, and active participation in CAPA investigations and implementation of corrective/preventive actions are also key. Learning FDA regulations (21 CFR Part 820) and ISO 13485 standards is part of the role.

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.