Senior Supplier Quality Validation Engineer

INTEGRA LIFESCIENCES SALES LLC; United States; On-site; USD 73,000 - 102,000; Full time

Benefits offered by this job

Health insurance

Job summary

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation with hands-on process validation experience to drive supplier quality improvements for new products and lifecycle changes. You will lead IQ/OQ/PQ activities and ensure timely completion while coordinating with suppliers and internal teams.

The role requires strong data analytics, regulatory knowledge (FDA/ISO), and collaboration across functions to sustain continuous improvement and CAPA execution.

Qualifications

• Experience in process validation and component qualification under cGMP.
• Familiarity with FDA/ISO 13485 requirements preferred.
• Strong analytical and statistical document interpretation skills.

Responsibilities

• Communicate, verify and execute process validations of supplier processes for Integra Codman and Tissue Technologies.
• Ensure CTQs, drawings, specifications and IQ/OQ/PQ protocols are completed and verified.
• Drive continuous improvement in supplier quality through data analysis.
• Lead for-cause audits to determine root cause and drive CAPAs.
• Review and approve qualification documentation with suppliers for new products and LCM.
• Provide training on Process Validation concepts to the team.
• Coordinate activities with other departments and external vendors.

Skills

Process Validation

IQ/OQ/PQ

Data Analytics

Quality Engineering

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Doctoral degree

Job description

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation with hands-on process validation experience to drive supplier quality improvements for new products and lifecycle changes. You will lead IQ/OQ/PQ activities and ensure timely completion while coordinating with suppliers and internal teams.

The role requires strong data analytics, regulatory knowledge (FDA/ISO), and collaboration across functions to sustain continuous improvement and CAPA execution.