Senior Supplier Quality Engineer - Audits & CAPA Leader

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Senior Supplier Quality Engineer I to bolster supplier quality systems at our Plainsboro, NJ site. You will lead supplier audits, coordinate quality reviews, and drive CAPA-driven improvements to meet FDA and ISO 13485 standards.

Travel up to 50% is expected. The role requires strong auditing experience in a regulated environment, plus expertise in eQMS and data-driven decision making.

Qualifications

• 5+ years of supplier quality experience.
• Lead auditor certification and/or CQA/CQE is highly desired.
• Experience in FDA controlled environment.
• Travel up to 50%.

Responsibilities

• Provide support to the Integra Plainsboro facility leading supplier quality projects and audits.
• Coordinate periodic quality reviews and support supplier-related business reviews.
• Issue and monitor SCARs to resolve supplier quality issues.
• Drive continuous improvement using defined criteria and metrics.
• Lead quality issue investigations and develop robust CAPA plans.
• Support integration of newly acquired businesses and ensure compliance with regulations.

Skills

Supplier Quality

Auditing

Quality Management

CAPA

Education

Bachelor's degree

Master's degree

Tools

eQMS software

Job description

Integra LifeSciences Corporation is seeking a Senior Supplier Quality Engineer I to bolster supplier quality systems at our Plainsboro, NJ site. You will lead supplier audits, coordinate quality reviews, and drive CAPA-driven improvements to meet FDA and ISO 13485 standards.

Travel up to 50% is expected. The role requires strong auditing experience in a regulated environment, plus expertise in eQMS and data-driven decision making.