Staff Quality Engineer

Role: Senior Supplier Quality Validation Engineer focused on process validation and continuous improvement within medical device manufacturing. Responsibilities include verifying and executing process validations (IQ/OQ/PQ) for supplier processes, ensuring compliance with quality standards (FDA, ISO 13485, cGMP), and supporting lifecycle change management projects. The role involves leading supplier audits, root cause analysis, CAPAs, and facilitating communication between the organization and suppliers to meet quality and validation timelines. Requirements: Bachelor's degree (10+ years), or advanced degrees with relevant experience in manufacturing or quality engineering; extensive experience in process validation, component qualification, and data analytics in a regulated medical device or pharmaceutical environment. Knowledge of ISO standards, FDA regulations, and GxP practices is essential. Preferred skills include strong collaboration in matrix organizations and proficiency with technical/statistical documentation. High-value details: 10% travel, international travel possible, supporting divisions like Codman Surgical and Tissue Technologies, and ensuring regulatory compliance across validation activities.