Senior Supplier Quality Engineer

Location:

Warren, New Jersey (minimum 3 days/week on site)

Salary Range: 125k–150k

• 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/5
  
  Why, data analysis) to prevent recurrence.

• 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.