Global Supplier Quality Engineer II — Hybrid Medical Device

Integra LifeSciences; Plainsboro Township (NJ); Hybride; USD 71 000 - 98 000; Plein temps

Avantages offerts par ce poste

401(k)

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Company-wide benefits

Résumé du poste

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to support supplier quality at our Plainsboro, NJ site. You will lead supplier audits, maintain supplier quality requirements, and provide QA leadership to contract manufacturers and raw material suppliers.

This hybrid role requires onsite presence at least three days a week, with travel up to 25%. Key duties include audits, CAPA, change control, supplier quality agreements, and ensuring compliance with FDA CFR 820 and ISO

Qualifications

• Bachelor's or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline.
• Experience in quality or manufacturing (minimum 3 years).
• Medical Device or Pharmaceutical experience is required.
• Familiarity with ISO 9001 and ISO 13485, 21 CFR 820 preferred.
• Travel up to 25% with possible international travel.
• Experience in FDA regulatory environments.
• Strong collaboration in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Knowledge of cGMP and applicable standards.
• Experience using analytical tools to drive data-based decisions.

Responsabilités

• Establishes and maintains an up-to-date Approved Supplier List.
• Plans and executes supplier audits in a timely manner.
• Conducts supplier audits per GMP, ISO, and regulatory requirements.
• Ensures measurement systems monitor supplier quality and prevent defects.
• Maintains supplier quality agreements for production suppliers.
• Provides technical support to QC, purchasing and production departments.
• Supports audits, inspections, CAPA, and change management per FDA/ISO standards.
• Addresses supplier change requests per procedures and regulatory requirements.
• Ensures validation of outsourced processes/products per procedures and timelines.
• Manages supplier non-conformances and investigations.
• Escalates supplier quality issues and proposes robust solutions.
• Leads continuous improvement and supplier management meetings at the Colombia site.

Connaissances

Supplier quality leadership

Auditing / supplier audits

CAPA and change management

Data-driven decision making

Cross-functional collaboration

Reading technical documents

Formation

Bachelor's or Master's in Engineering/Related

Outils

Analytical tools

Description du poste

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to support supplier quality at our Plainsboro, NJ site. You will lead supplier audits, maintain supplier quality requirements, and provide QA leadership to contract manufacturers and raw material suppliers.

This hybrid role requires onsite presence at least three days a week, with travel up to 25%. Key duties include audits, CAPA, change control, supplier quality agreements, and ensuring compliance with FDA CFR 820 and ISO