Summary: As a Senior Global Supplier Quality Engineer, you will provide strategic technical oversight of global suppliers, ensuring design intent, process capability, and product performance are achieved across complex components. Highlights: 1. Lead qualification and lifecycle management of critical global suppliers 2. Provide expert technical oversight during supplier process development 3. Lead complex cross-site root cause investigations using advanced methodologies **Job Requisition No** VN8399 **Work Location Name** Spain \- Remote **Worker Basis** Full Time **Worker Type** Employee **Contract Type** Permanent **Applications Close Date** **Purpose** As a Senior Global Supplier Quality Engineer, you will provide strategic technical oversight of global suppliers from qualification through lifecycle management, ensuring design intent, process capability, and product performance are consistently achieved across complex, high\-risk components, assemblies, and finished goods. You will act as the technical authority for supplier process engineering, manufacturing controls, and advanced quality planning, driving risk mitigation and continuous improvement across multiple sites. This position requires Right to work in Poland and availability to travel freely within the EU. **Key Responsibilities** * Lead qualification, performance monitoring, and lifecycle management of critical global suppliers in collaboration with cross\-functional stakeholders * Provide expert technical oversight during supplier process development, scale\-up, validation, and production transfer * Conduct deep technical reviews of supplier processes including PFMEA, control plans, validation protocols, and capability studies * Lead complex cross\-site root cause investigations (CAPA, NC, SCAR) using advanced engineering methodologies and ensure effective corrective actions * Define and execute global supplier quality strategies aligned with business objectives, technology roadmaps, and risk\-based sourcing plans * Represent Supplier Quality in global NPD projects, ensuring Design for Manufacture, Design for Assembly, and supplier readiness * Lead supplier audits and drive sustainable quality improvement plans across global supplier networks * Assess and manage supplier\-initiated changes and internal changes impacting supplier processes * Prepare and present quality performance summaries to senior leadership and support customer and regulatory audits * Develop and maintain quality and purchasing specifications to ensure consistent implementation across suppliers **Qualification** * Bachelor’s degree in Engineering, Science, or related discipline * 10 years of experience in Quality Engineering or Supplier Quality within the medical device or pharmaceutical industry * Certified Lead Auditor to ISO 13485 * Strong knowledge of manufacturing technologies such as precision machining, injection molding, laser processing, coatings, electronics assembly, and component manufacturing * Advanced ability to interpret engineering drawings, GD\&T, tolerance analysis, and material specifications * Deep understanding of global regulatory frameworks (FDA QMSR/QSR, ISO 13485, ISO 14971, EU MDR, MDSAP) * Proven ability to influence senior stakeholders through data\-driven recommendations and technical expertise * Ability to navigate ambiguity and drive decisions in fast\-paced, global environments * Availability to travel 30–50% of the time, depending on the month and project scope, including travel to Mexico and the United States * Flexibility to accommodate occasional work across Mexico and US time zones, particularly during audits and critical project phases **Company** BVI® is refocusing the future of vision. As one of the fastest\-growing, diversified surgical ophthalmic businesses in the world, our purpose\-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single\-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at www.bvimedical.com