Senior Supplier Quality Engineer
DBV Technologies
12 days ago
On-site
Warren, NJ
Operations
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 follow-up of CAPA effectiveness.
- 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 and applied.
- Support SOPs for Supplier Management; align with global procedures and coach teams on process adherence.
- Ensure readiness for inspections (e.g., FDA, EU) and PAI: maintain supplier files, monitor GMP certificates/expirations, and prepare audit/inspection evidence.
- Provide quality engineering support (incoming controls, sampling plans, problem solving via 8D/5Why, data analysis) to prevent recurrence.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field (Master’s preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent experience; 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.
Salary Range: 125k–150k
Key Responsibilities:
- Support the audit program: annual plan, execution, reporting, and follow-up of CAPA effectiveness.
- 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 and applied.
- Support SOPs for Supplier Management; align with global procedures and coach teams on process adherence.
- Ensure readiness for inspections (e.g., FDA, EU) and PAI: maintain supplier files, monitor GMP certificates/expirations, and prepare audit/inspection evidence.
- Provide quality engineering support (incoming controls, sampling plans, problem solving via 8D/5Why, data analysis) to prevent recurrence.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field (Master’s preferred).
- Formal auditor training (ISO 13485, GMP) required or equivalent experience; 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.