Senior Supplier Quality & Process Validation Engineer

Integra-Lifesciences; Princeton (NJ); On-site; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation Engineer with extensive experience in process validation and supplier quality management. The role focuses on IQ/OQ/PQ execution, data-driven improvement, and cross-functional collaboration to support new products and lifecycle changes.

Responsibilities include leading supplier validations, audits, CAPAs, and ensuring documentation is accurate and timely.

Qualifications

• Experience in process validation and component qualification (IQ/OQ/PQ) with data analytics.
• Experience in Medical Device or Pharmaceutical environments; ISO 9001/13485 knowledge preferred.
• Ability to read and interpret technical and statistical documents; interface with technical and non-technical personnel.

Responsibilities

• Communicate, verify and execute process validations of supplier processes (IQ/OQ/PQ) and related protocols.
• Drive continuous improvement in supplier quality through data analysis and CAPA.
• Lead supplier audits/visits and support site supplier quality teams.
• Review and approve IQ/OQ/PQ documentation for new products and LCM projects.
• Coordinate with other departments, vendors and customers to ensure compliance with regulations.

Skills

Process validation

IQ/OQ/PQ

Data analytics

Cross-functional collaboration

Communication

Education

Bachelor's degree in Mechanical/Industrial Engineering or related

Master's degree

Doctoral degree

Job description

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation Engineer with extensive experience in process validation and supplier quality management. The role focuses on IQ/OQ/PQ execution, data-driven improvement, and cross-functional collaboration to support new products and lifecycle changes.

Responsibilities include leading supplier validations, audits, CAPAs, and ensuring documentation is accurate and timely.