Senior Supplier Quality Engineer

Role: Lead supplier quality activities ensuring externally supplied materials and services meet GMP, ISO 13485, and internal standards. Responsibilities: support audit program, manage CAPA follow-up, maintain supplier risk assessments and performance reviews, lead QTA lifecycle management, ensure compliance for inspections, and provide quality engineering support. Requirements: Bachelor's in Engineering, Life Sciences, Pharmacy or related field; 5–8 years in Supplier Quality or Quality Engineering, preferably in pharma or biologics; formal auditor training (ISO 13485, GMP) and experience leading audits; knowledge of FDA, EU GMP, ISO standards; proficiency with eQMS systems. Preferred: Master’s degree, Lead Auditor certification. HighValue: supplier quality in biopharma, GMP, ISO 13485, audit management, CAPA, QTAs, pharma validation, regulatory inspection readiness. WorkSetup: Warren, NJ, minimum 3 days on-site.