Global Supplier Quality Engineer II

Role: Global Supplier Quality Engineer II supporting supplier quality assurance at Integra's Plainsboro, NJ manufacturing site. Primary objectives include conducting supplier audits, maintaining supplier quality requirements, and supporting quality systems in compliance with GMP, ISO standards, and regulatory requirements. Responsibilities encompass managing supplier qualification processes, conducting audits per GMP/ISO, supporting supplier quality agreements, providing technical QA support to internal departments, managing change requests, validation activities, non-conformance investigations, and participating in continuous improvement initiatives. Qualifications: Bachelor's or master's degree in engineering or sciences; minimum 3 years in quality or manufacturing, with experience in medical device or pharmaceutical sectors; familiarity with ISO 9001, ISO 13485, 21 CFR 820, and FDA regulations preferred. High-Value: experience in regulated environments, supplier audits, validation, CAPA, and supplier management within medical device or pharma manufacturing. Work setup: hybrid role requiring at least 3 days onsite in Plainsboro, NJ, with travel up to 25%, including potential international travel.