Distributor Quality Specialist

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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 Distributors Quality specialist is in charge of supporting all international departments, especially EMEA ones, in setting up and deploying harmonized and compliant processes with Integra distributors for marketing, selling and distribution activities of Integra products. These activities include, but are not limited to launching new products, all new business projects, quality and compliance issues, etc.
The Distributors Quality specialist is responsible for ensuring that distributors meet and respect Integra requirements as well as regulatory ones.

RESPONSIBILITIES

Process management and business support:

- Support Sales team and Regulatory Affairs team to include new distributors
- Implement as needed processes to manage activities with distributors
- Define and maintain list of active distributors
- Support sales team to draft quality agreements with distributors, review agreements and ensure they are signed before starting commercial activities
- Implement metrics and KPI
- Review and update periodically and as needed the procedures related to distributor management processes
- Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistent with global standards
- Collect and archive quality records requested as per the quality agreements
- Review and store promotional materials designed by the distributors
- Support EMEA Quality for managing changes process when needed

Product Compliance:

- 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 for complaints related to distribution issues
- 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.
- 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, GxP, 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 during Due diligence.

QUALIFICATIONS / EXPERIENCE & INTERPERSONAL SKILLS
- Bachelor’s Degree in LifeSciences, Master (in Quality), Advanced Degree (Engineer, MBA, MPA, MPH, PhD, Pharm D) desirable
- 3 to 5 years’ experience in Quality Assurance functions or at least 3 years spent in a Quality role. Understanding of all quality, GxP standards as well as medical devices regulatory requirements especially for FSN/Recall activities. Strong knowledge of the Medical Device Industry and related policies.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation
- Fluent English
- Strong analytic skills and ability to provide insight into quality issues
- Must be willing to travel Internationally