Staff Quality Engineer – Supplier Validation

About the role

This position is for a Staff Engineer – Supplier Quality Validation Engineer responsible for ensuring timely completion of process validation requirements for new products and lifecycle change management projects with suppliers, in accordance with Integra’s quality standards.

Key responsibilities

• Communicate, verify, and execute IQ/OQ/PQ validations for supplier processes supporting Integra Codman Specialty Surgical and Tissue Technologies divisions.
• Drive continuous improvement in supplier quality through data analysis, root‑cause investigations, and CAPA implementation.
• Lead for‑cause audits, supplier visits, and support site supplier quality teams on critical issues.
• Review and approve qualification documentation for new product and LCM projects.
• Support supplier consolidation initiatives and provide training on process validation concepts.

Required profile

• Bachelor’s degree (or higher) in Manufacturing, Mechanical, Industrial Engineering, Quality or related field with 10+ years of experience (or equivalent experience levels as listed).
• Strong experience in medical device or pharmaceutical environments, including FDA‑regulated and ISO‑based quality systems.
• Fluent English with excellent communication and collaboration skills in a matrix organization.

Required skills

• Process validation expertise (IQ, OQ, PQ) and component qualification.
• Data analytics and statistical analysis for decision‑making.
• Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 11, cGMP and related regulatory requirements.
• Root‑cause analysis, CAPA development, and audit execution.
• Use of analytical tools to drive continuous improvement.

What we offer

• Comprehensive medical, dental, vision, life insurance and disability benefits.
• 401(k) savings plan and other employee benefit programs.