Senior Quality Technician – Medical Devices & CAPA Leader

Freudenberg Medical, LLC; Jeffersonville (IN); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

401K Match

Diversity & Inclusion

Personal Development

Safe Environment

Corporate Events

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CAPA investigations

Root cause analysis

Statistical quality

Regulatory compliance

Quality systems

Formation

Bachelor’s degree in Engineering/Quality

Description du poste

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.