Quality Technician II

Freudenberg Management (Shanghai) Co. Ltd.; Jeffersonville (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

Freudenberg Medical LLC in Indiana is seeking a quality professional to apply QMS procedures, GMP principles, and risk management in daily tasks and audits.

The role focuses on product testing, statistical methods, and CAPA execution, with training on FDA regulations (21 CFR Part 820) and ISO 13485 standards; strong collaboration and continuous improvement expected.

Qualifications

• High school diploma or equivalent.
• Certification or associate’s degree preferred.
• ~3+ years relevant experience.

Responsibilities

• Understand and apply procedures to daily tasks.
• Troubleshoot basic issues in manufacturing.
• Manage consumables and maintain the work area.
• Share knowledge with peers.
• Receive guidance and direction as needed.
• Apply QMS procedures in audits and daily work.
• Adhere to GMP principles in medical device manufacturing.
• Test and inspect products using approved methodologies.
• Use statistical methods, process control, and quality tools (Six Sigma, DOE, FMEA).
• Maintain risk management documentation (ISO 14971) for risk mitigation and changes.
• Participate in CAPA investigations and implement corrective/preventive actions.
• Learn FDA regulations (21 CFR Part 820) and ISO 13485 standards.

Skills

QMS procedures

GMP principles

Product testing

Statistical methods

Process control

Six Sigma

DOE

FMEA

CAPA investigations

FDA regulations

ISO 13485

Risk management

Change management

ISO 14971

Education

High school diploma

Associate degree preferred

Certification preferred

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