Sr Quality Technician

Freudenberg Group; Jeffersonville (IN); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Freudenberg Group in Indiana seeks a Quality Engineer/Quality Systems professional with 3–5+ years in the medical device sector. You will apply FDA QSR, ISO 13485, EU MDR and GMP knowledge to drive CAPA, nonconformances, change control, and process validation across manufacturing teams.

You will lead investigations, analyze quality data, and collaborate with Manufacturing, Engineering, and Operations to ensure product quality and regulatory compliance throughout the product lifecycle.

Formación

• 3–5+ years in the medical device industry, incl. at least 3 years in Quality Engineering or Quality Systems.
• Proven experience with nonconformance management, CAPA, root cause analysis, and product quality.
• Experience in a regulated manufacturing environment.
• Strong knowledge of FDA Quality System requirements, ISO 13485, EU MDR, GMP.
• Understanding of quality system requirements and industry best practices.
• Experience managing and investigating nonconformances and leading CAPA activities.
• 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/preventive actions.
• Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.

Responsabilidades

• Apply procedures and equipment understanding to ensure compliant manufacturing.
• Lead CAPA investigations and implement corrective actions.
• Train and mentor junior staff, act as a resource for colleagues.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and GMP.
• Support design control and design transfer activities.
• Participate in internal and external audits.
• Perform product testing, inspection, and statistical quality control.
• Identify quality data trends and drive improvements across processes.

Conocimientos

Quality engineering

CAPA

Root cause analysis

Nonconformance management

Process validation

Change control

Software validation

Quality data analysis

Cross-functional collaboration

Regulatory knowledge

Educación

Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or related field

Descripción del empleo

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