Senior Quality Specialist, Distribution

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

FR-xx-Saint Priest-421-Facility

Full time

JR-6240

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Senior Quality Specialist, Distribution, is responsible for supporting all international departments, in the EMEA region and beyond, in establishing and deploying harmonized and compliant processes with Integra distributors for the marketing, sale, and distribution of Integra products. These activities include, but are not limited to, new product launches, new business projects, and quality and compliance matters.

The Senior Quality Specialist, Distribution, also supports activities related to external products distributed by ILS France in EMEA (with Integra acting as a service provider/distributor), as well as selected Quality System Management (QMS) activities to ensure ongoing compliance and operational effectiveness.

RESPONSIBILITIES

Process management and business support:

• Define and maintain the list of active distributors with Agreements, within a database.

• Ensure Distributors Quality Agreements (DQA) are signed and reviewed periodically with distributors

• Support sales and operations teams to include new distributors, draft or review distributor quality agreements and ensure they are signed before starting commercial activities

• Implement and follow metrics

• Review, implement and update periodically and as needed the procedures related to distributor management processes

• Manage activities related to external products distributed by Integra (documentation review, agreements, products creation or update in Agile system)

• Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistently with global standards

• Collect and archive quality records requested as per the quality and/or distribution agreements

• Support EMEA Quality for managing QMS activities when needed (review of procedure, change process, training …etc.)

• Support Environmental projects and questions for EMEA QMS.

Product Compliance:

• Manage non-conformities related to products received at the distribution center that ILS France distributes in Europe.

• Ensure products are handled and stored by the distributors, in compliance with manufacturers’ requirements

• Support Post Market Surveillance (PMS) team and work with distributors for any field safety actions

• Review and support investigations of complaints related to distribution issues (for Integra and non-Integra products)

• Collaborate with European and US Quality teams and with the Distribution Quality team to ensure quality concerns are addressed early in the process and appropriate strategies are developed.

Audits:

• Support any internal and external audits.

• Perform internal audits and audit distributors’ premises when necessary

• Keep appraised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the distribution of Integra medical devices.

• Perform training according to ISO standards, Integra Policy and any medical devices regulatory requirements.

Technical:

• Knows, understands, and commits to respecting the INTEGRA Group promises/commitments, the Quality policy, the safety charter as well as all the rules and processes applicable to the role.

Other:

• Act as quality point of contact for the international sales team and distributors
• Perform all other related duties as directed by management,
• Perform quality activities required during Due diligence.

QUALIFICATIONS / EXPERIENCE & INTERPERSONAL SKILLS

Education: Bachelor’s Degree in LifeSciences, Master (in Quality), Advanced Degree (Engineer, MBA, MPA, MPH, PhD, Pharm D) desirable

Type and Number Years of Experience: 5 to 7 years’ experience in Quality Assurance functions or at least 5 years spent in a Quality role.

Strong knowledge of ISO13485, ISO9001, and the Medical Device Industry and related regulations and policies.

Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation

Fluent English

Audit skills

Strong analytic skills and ability to provide insight into quality issues

Must be willing to travel Internationally

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) is position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Whatever your specialty, you’ll find an ideal setting for building a rewarding career.

Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.