Sr Quality Technician

Freudenberg Medical, LLC; Jeffersonville (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

401K Match

Diversity & Inclusion

Personal Development

Safe Environment

Corporate Events

Job summary

Freudenberg Medical LLC in Jeffersonville, IN is seeking a Senior Quality Technician to support quality systems in a regulated medical device environment. The role emphasizes CAPA, root cause analysis, and continuous improvement across manufacturing processes.

You will apply FDA 21 CFR Part 820, ISO 13485, GMP, and risk management practices to maintain product quality and compliance, while collaborating with cross‑functional teams and mentoring junior staff.

Qualifications

• 3–5+ years in the medical device quality field.
• Experience with nonconformance management, CAPA, root cause analysis.
• Bachelor’s degree in Engineering or related field preferred.
• Experience in regulated manufacturing with GMP and ISO 13485.
• Experience with process validation and change control.

Responsibilities

• Advanced understanding of procedures and equipment.
• Resolves most issues independently.
• Leads CAPA investigations and implements corrective actions.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and GMP.
• Participation in internal and external audits.
• Leads by example and trains junior staff or acts as a resource for colleagues.

Skills

CAPA investigations

Root cause analysis

Statistical quality

Regulatory compliance

Quality systems

Education

Bachelor’s degree in Engineering/Quality

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.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.
• 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

Sr Quality Technician

Responsibilities

• Advanced understanding of procedures and equipment.
• Resolves most issues independently.
• Prioritizes tasks and supports training.
• Leads by example and formally trains junior staff or acts as a resource for colleagues with less experience.
• Proficient in applying FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
• Strong understanding of GMP principles and quality assurance practices.
• Skilled in product testing, inspection, and statistical quality control.
• Proficient in risk management methodologies and post-market surveillance.
• Ability to lead CAPA investigations and implement sustainable corrective actions.
• Familiarity with design control processes to ensure compliance with performance criteria.
• Participation in internal and external audits.

Qualifications

• 3–5+ years of experience in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems.
• Proven experience with nonconformance management, CAPA, root cause analysis, and product quality.
• Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or a related technical field preferred will take experience in lieu of degree
• Experience working within a regulated manufacturing environment.
• Strong working knowledge of medical device quality and regulatory requirements, including: FDA Quality System requirements ISO 13485 EU Medical Device Regulation (EU MDR) Good Manufacturing Practices (GMP)
• Understanding of quality system requirements and industry best practices.
• Experience managing and investigating nonconformances.
• Experience leading CAPA activities and root cause investigations.
• Experience with process validation and manufacturing process controls.
• Experience with change control and change management.
• Experience with software validation, as applicable.
• Ability to analyze quality data, identify trends, and drive corrective and preventive actions.
• Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.

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.