Senior Supplier Quality Validation Engineer

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

Job summary

Integra LifeSciences in New Jersey is seeking a Staff Engineer - Supplier Quality Validation Engineer with hands-on experience in process validation and supplier collaboration to ensure timely completion of IQ/OQ/PQ for new products and life cycle changes. You will drive continuous improvement in supplier quality, lead supplier audits and CAPAs, and guide cross-functional teams to meet FDA/ISO requirements.

Travel up to 10% may be required.

Qualifications

• Bachelor's degree or equivalent in manufacturing/engineering with 10+ years of experience (or advanced degrees with applicable years).
• Master's degree with 8+ years of experience; Doctoral with 5+ years.
• Experience in medical device/pharma, ISO 9001/13485 knowledge, FDA exposure.

Responsibilities

• Communicate and execute process validations for supplier processes tied to Integra products.
• Ensure IQ/OQ/PQ protocols are communicated, completed, and verified for each group.
• Drive continuous improvement in supplier quality through data analysis.
• Lead for-cause audits to identify root causes and drive CAPAs.
• Review and approve qualification documentation for new products and LCM projects.
• Develop and deliver training on Process Validation concepts to teams.
• Coordinate activities with other departments and suppliers; ensure regulatory compliance.

Skills

Fluent English

Process validation IQ/OQ/PQ

FDA/regulatory experience

cGMP knowledge

Data analytics

Collaborative skills

Technical/document reading

Education

Bachelor's degree or equivalent in manufacturing/engineering

Master's degree in engineering

Doctoral degree in engineering

Job description

Integra LifeSciences in New Jersey is seeking a Staff Engineer - Supplier Quality Validation Engineer with hands-on experience in process validation and supplier collaboration to ensure timely completion of IQ/OQ/PQ for new products and life cycle changes. You will drive continuous improvement in supplier quality, lead supplier audits and CAPAs, and guide cross-functional teams to meet FDA/ISO requirements.

Travel up to 10% may be required.