Senior Quality Specialist, Distribution

Job description

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) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.