Senior Global Supplier Quality Engineer
Full details of the job.
Work Location Name: Italy - Remote
Worker Basis: Full Time
Worker Type: Employee
Contract Type: Permanent
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
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