Senior Supplier Quality Engineer
DBV Technologies
August 20, 2026
Remote friendly (Warren, NJ)
United States
Operations
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) with the Supplier Owner and cross-functional teams.
Location: Warren, New Jersey (minimum 3 days/week on site)
Salary Range: $125k–$150k
Key Responsibilities:
- Support the audit program: annual plan, execution, reporting, and CAPA effectiveness follow-up.
- Maintain supplier risk assessment, segmentation, and performance reviews; drive supplier improvement actions.
- Lead QTA lifecycle: creation, review, Procurement negotiation support, and periodic updates; ensure RACI is defined/applied.
- Support SOPs for Supplier Management; align with global procedures and coach process adherence.
- Ensure readiness for inspections (FDA/EU) and PAI: maintain supplier files (GMP certificates), monitor expirations, prepare audit/inspection evidence.
- Provide quality engineering support (incoming controls, sampling plans, 8D/5Why problem solving, data analysis) to prevent recurrence.
Qualifications:
- Bachelor’s in Engineering, Life Sciences, Pharmacy, or related field (Master’s preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent; Lead Auditor certification preferred.
- 5–8 years in Supplier Quality/Quality Engineering in medical device and/or pharma (Pharma/Biologics preferred).
- 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 a plus), supplier performance dashboards, and RACI implementation.
- Fluent in English; strong communication and stakeholder influencing skills.
Location: Warren, New Jersey (minimum 3 days/week on site)
Salary Range: $125k–$150k
Key Responsibilities:
- Support the audit program: annual plan, execution, reporting, and CAPA effectiveness follow-up.
- Maintain supplier risk assessment, segmentation, and performance reviews; drive supplier improvement actions.
- Lead QTA lifecycle: creation, review, Procurement negotiation support, and periodic updates; ensure RACI is defined/applied.
- Support SOPs for Supplier Management; align with global procedures and coach process adherence.
- Ensure readiness for inspections (FDA/EU) and PAI: maintain supplier files (GMP certificates), monitor expirations, prepare audit/inspection evidence.
- Provide quality engineering support (incoming controls, sampling plans, 8D/5Why problem solving, data analysis) to prevent recurrence.
Qualifications:
- Bachelor’s in Engineering, Life Sciences, Pharmacy, or related field (Master’s preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent; Lead Auditor certification preferred.
- 5–8 years in Supplier Quality/Quality Engineering in medical device and/or pharma (Pharma/Biologics preferred).
- 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 a plus), supplier performance dashboards, and RACI implementation.
- Fluent in English; strong communication and stakeholder influencing skills.