Global Quality Specialist – Distribution & Compliance

Integra LifeSciences Corporation; Lyon; On-site; EUR 60,000 - 78,000; Full time

Job summary

Integra LifeSciences Corporation in Lyon seeks a Senior Quality Specialist, Distribution, to harmonize and oversee distributor quality processes across the EMEA region. You will drive distributor agreements, lead quality initiatives, and ensure compliance for Integra medical devices.

The role requires 5–7 years in quality functions, strong ISO knowledge, and willingness to travel internationally. Collaboration with European and US teams is key to success.

Qualifications

• Bachelor’s degree in Life Sciences or related field and a Master in Quality preferred.
• 5–7 years in Quality Assurance or at least 5 years in a Quality role in medical devices.
• Strong knowledge of ISO13485 and ISO9001 regulations for medical devices.
• Fluent in English and able to travel internationally.

Responsibilities

• Define and maintain active distributor lists with agreements.
• Manage Distributor Quality Agreements (DQA) and periodic reviews.
• Support distributor onboarding, draft agreements, and ensure signing before activity.
• Implement metrics and update distributor management procedures.
• Oversee QA activities for external products distributed by Integra France in Europe.
• Manage quality projects and resolve issues per global standards.
• Archive quality records per agreements and assist EMEA QMS activities.
• Support PMS investigations and field safety actions with distributors.
• Assist with internal and external audits and regulatory training.

Skills

Project management

Auditing

Analytical skills

Fluent English

International travel

Education

Bachelor’s Degree in LifeSciences

Master in Quality

Advanced degree (Engineer/MBA/MPA/ MPH/PhD/Pharm D)

Job description

Integra LifeSciences Corporation in Lyon seeks a Senior Quality Specialist, Distribution, to harmonize and oversee distributor quality processes across the EMEA region. You will drive distributor agreements, lead quality initiatives, and ensure compliance for Integra medical devices.

The role requires 5–7 years in quality functions, strong ISO knowledge, and willingness to travel internationally. Collaboration with European and US teams is key to success.