Sr Quality Technician

Freudenberg; Jeffersonville (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Freudenberg is seeking a Quality Engineer to advance medical device quality systems in Indiana. You will apply FDA QSR (21 CFR 820), ISO 13485, and EU MDR, lead CAPA investigations, perform root cause analyses, and drive process validation and manufacturing controls.

You'll collaborate with Manufacturing, Engineering, and Operations to address nonconformances and support audits. The role emphasizes quality data analysis, risk management, and design control familiarity, with opportunities to

Qualifications

• 3–5+ years in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems.
• Experience with nonconformance management, CAPA, root cause analysis, and product quality.
• Strong working knowledge of medical device quality and regulatory requirements, including FDA Quality System requirements ISO 13485 EU MDR GMP.
• 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.

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.

Skills

CAPA investigations

Root cause analysis

Nonconformance mgmt

Regulatory knowledge

Quality data analysis

Process validation

Change control

Cross-functional collaboration

Software validation

Education

Bachelor’s degree in Engineering/Quality/Biomedical Engineering

Job description

Working at Freudenberg: We will wow your world!

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.

Freudenberg Medical LLC

Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. 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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.