Senior Quality Specialist, Distribution

Integra LifeSciences; Saint-Priest; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Integra LifeSciences seeks a Senior Quality Specialist, Distribution, to support international quality processes across the EMEA region and beyond. You will ensure distributor quality agreements, manage QMS activities, and supervise quality projects aligned with global standards.

Requires 5–7 years in QA, strong knowledge of ISO13485/ISO9001, fluent English, audit and analytics skills, and willingness to travel internationally; based in France with on-site work in centralized distribution hubs.

Qualifications

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

Responsabilités

• 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.
• 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.
• 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.
• 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.
• 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.

Connaissances

Fluent English

Audit skills

Analytical skills

Project management

Willing to travel internationally

Formation

Bachelor’s Degree in Life Sciences

Master in Quality

Advanced degree desirable

Description du poste

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