Global Quality Operations Director – EU Sites & Compliance

Integra LifeSciences Corporation; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Sr Director to oversee Quality operations in Indiana. Responsibilities include ensuring compliance with FDA QSR, ISO 13485, and EU MDR across multiple sites while fostering a culture of quality excellence.

The ideal candidate will have at least 10-12 years of progressive Quality experience in the medical device industry, with a strong track record in regulatory inspections and leading Quality organizations.

Qualifications

• Minimum of 10-12 years of progressive Quality experience in the medical device industry.
• Demonstrated experience leading Quality organizations in a manufacturing environment.
• Proven experience leading regulatory inspections.

Responsibilities

• Ensure ongoing compliance with applicable regulations and standards.
• Partner with Site Leadership, Operations, Regulatory, and Corporate Quality.
• Drive a culture of quality excellence and continuous improvement.

Skills

Quality experience in the medical device industry

Leading Quality organizations

Knowledge of FDA QSR

Knowledge of ISO 13485

Knowledge of EU MDR

Job description

Integra LifeSciences Corporation is seeking a Sr Director to oversee Quality operations in Indiana. Responsibilities include ensuring compliance with FDA QSR, ISO 13485, and EU MDR across multiple sites while fostering a culture of quality excellence.

The ideal candidate will have at least 10-12 years of progressive Quality experience in the medical device industry, with a strong track record in regulatory inspections and leading Quality organizations.