Senior Supplier Quality Engineer: Elevate Quality & Compliance

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 95,000 - 125,000; Full time

Job summary

Integra LifeSciences Corp is seeking a Sr. Supplier Quality Engineer I for our Plainsboro, NJ site. The role focuses on building a robust supplier quality system, leading audits, CAPA, SCAR resolution, and continuous improvement across supplier networks.

You will work within a regulated environment, coordinating with multiple departments and suppliers to ensure quality, compliance, and efficient manufacturing processes at the new state-of-the-art facility in Plainsboro.

Qualifications

• Bachelor's or Master's degree with relevant supplier quality experience or equivalent education.
• Lead auditor certification and/or CQA/CQE is highly desired.
• Minimum 5 years of supplier quality experience and/or supplier auditing in regulated environments.
• Experience in FDA controlled environments and knowledge of cGMP/cGMP processes.

Responsibilities

• Support Supplier Quality at Integra Plainsboro through audits and supplier projects.
• Coordinate periodic quality reviews with key suppliers and internal stakeholders.
• Resolve supplier quality issues by issuing and monitoring SCARs.
• Drive continuous improvement using defined metrics and data analyses.
• Lead CAPA investigations and develop robust corrective action plans.
• Support integration of acquired businesses.
• Ensure compliance with FDA, ISO 13485, CMDR, MDR, JPAL and 21 CFR Part 11; collaborate across departments.
• Communicate company goals and policies to teams to achieve quality and profitability.

Skills

Auditing

Regulatory compliance

Data analysis

Collaboration

Travel readiness

Education

Bachelor's degree in related field

Master's degree in related field

Tools

eQMS software

Job description

Integra LifeSciences Corp is seeking a Sr. Supplier Quality Engineer I for our Plainsboro, NJ site. The role focuses on building a robust supplier quality system, leading audits, CAPA, SCAR resolution, and continuous improvement across supplier networks.

You will work within a regulated environment, coordinating with multiple departments and suppliers to ensure quality, compliance, and efficient manufacturing processes at the new state-of-the-art facility in Plainsboro.