Senior Supplier Quality Engineer

DBV Technologies is hiring a Senior Supplier Quality Engineer to lead supplier quality activities and ensure externally supplied materials, components, and services meet GMP, ISO 13485, and internal standards. The role supports supplier audits, CAPA follow-up, Quality Technical Agreements, inspection readiness, and quality engineering activities.

Responsibilities:

• Support the audit program: annual plan, execution, reporting, and follow-up of CAPA effectiveness
• Maintain supplier risk assessment, segmentation, and performance reviews; drive improvement actions with suppliers
• Lead QTA lifecycle: creation, review, negotiation support with Procurement, and periodic updates; ensure RACI is defined and applied
• Support SOPs for Supplier Management and ensure alignment with global procedures, coach teams on process adherence
• Ensure readiness for inspections (e.g., FDA, EU) and PAI: maintain supplier files GMP certificates, monitor expirations, and prepare audit/inspection evidence
• Provide quality engineering support (incoming controls, sampling plans, problem solving 8D/5Why, data analysis) to prevent recurrence of issues

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Pharmacy or related field
• Formal auditor training (ISO 13485, GMP) required or equivalent experience
• 5–8 years in Supplier Quality/Quality Engineering in medical device and/or pharma
• Proven experience leading supplier audits, managing CAPA, and implementing QTAs
• Working knowledge of FDA 21 CFR Parts 820/210/211/600/610/680, EU GMP, ISO 13485, ISO 14971
• Experience with eQMS (Veeva or ENNOV is a +), supplier performance dashboards, and RACI implementation
• Fluent in English; strong communication and stakeholder influencing skills
• Master's
• Lead Auditor certification
• Pharma/Biologics