Senior Supplier Quality Engineer — Auditor & CAPA Lead

Integra-Lifesciences; Plainsboro Township (NJ); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

Integra LifeSciences in Plainsboro, NJ is hiring a Sr. Supplier Quality Engineer I to lead supplier quality initiatives at our state-of-the-art site. You will conduct supplier audits, manage SCARs, CAPAs, and drive continuous improvement in a regulated FDA/cGMP environment.

The role requires 5+ years in supplier quality, auditing, and a lead auditor certification is highly desired. Travel up to 50% and collaboration across functions are essential to ensure quality across acquisitions and supply

Qualifications

• Bachelor's degree with 5+ years supplier quality experience or Master's with 3+ years.
• Lead auditor certification and/or CQI/CQE highly desired.
• Minimum 5 years of experience in supplier auditing.
• Experience in FDA controlled environment.
• Strong knowledge of cGMP and related standards.
• Experience using analytical tools to drive data-based decisions.
• Experience with eQMS software solutions preferred.
• Willingness to travel up to 50%.

Responsabilités

• Support Supplier Quality projects and audits at the Plainsboro site.
• Coordinate quality reviews and supplier business reviews.
• Resolve quality issues via SCARs and CAPA lifecycle.
• Drive continuous improvement with suppliers based on metrics.
• Lead quarterly Quality Management Reviews.
• Assist integration of newly acquired businesses.

Connaissances

Supplier quality

Auditing

Regulatory knowledge

Data analysis

Formation

Bachelor's degree

Master's degree

Outils

eQMS software

Description du poste

Integra LifeSciences in Plainsboro, NJ is hiring a Sr. Supplier Quality Engineer I to lead supplier quality initiatives at our state-of-the-art site. You will conduct supplier audits, manage SCARs, CAPAs, and drive continuous improvement in a regulated FDA/cGMP environment.

The role requires 5+ years in supplier quality, auditing, and a lead auditor certification is highly desired. Travel up to 50% and collaboration across functions are essential to ensure quality across acquisitions and supply