Senior Director, Quality Operations EU

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

breaker, this role oversees Quality operations for the Le Locle, St. Aubin, and RW sites, ensuring consistent execution of global Quality systems, regulatory compliance, and inspection readiness. Based in Le Locle, Switzerland, the Sr Director partners closely with Site Leadership, Operations, Regulatory, and Corporate Quality to safeguard product quality, patient safety, and business continuity while driving a culture of quality excellence and continuous improvement.**Key Responsibilities**Ensure ongoing compliance with applicable regulations and standards, including FDA QSR, ISO 13485, EU MDR, and other global regulatory requirements.**Required Qualifications**Minimum of 10-12 years of progressive Quality experience in the medical device or regulated healthcare industry.Demonstrated experience leading Quality organizations in a manufacturing environment.Strong working knowledge of global Quality and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR.Proven experience leading regulatory inspections and audits.Experience managing across multiple sites or complex organizations.**Preferred Qualifications**Prior experience in a Directorlevel or equivalent senior Quality leadership role.Experience serving as a spanExperience working within a global or multinational organization.