Quality Engineering Senior
DBV Technologies
Lead supplier quality activities to ensure externally supplied materials, components, and services meet GMP, ISO 13485, and internal standards. Support the audit program, CAPA follow-up, and Quality Technical Agreements (QTAs) in partnership with Supplier Owner and cross-functional teams.
Location: Warren, New Jersey -Minimum 3 days a week on site
Maintain supplier risk assessment, segmentation, and performance reviews; 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.
Bachelor's degree in Engineering, Life Sciences, Pharmacy or related field (Master's preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent experience; 5-8 years in Supplier Quality/Quality Engineering in medical device and/or pharma. Pharma/Biologics preferred.
- 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; Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
Department Quality Locations US - Warren, NJ Remote status Hybrid Employment type Full-time
Vacancy posted 16 hours ago
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