Quality Technician II

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

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 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

• 401K Match: Save for retirement with the company's help.


• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.


• Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.


• Personal Development: We offer a variety of trainings to ensure you can develop in your career.


• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.


• *Candidates must be legally authorized to work in the United States without current or future visa sponsorship


• We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.

Jeffersonville, IN
On-Site
Freudenberg Medical LLC

You support our team as

Quality Technician II

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.