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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