Quality Engineer

Responsibilities :

• Ensure proper integration and support of quality regulations : drug, biologics, device and / or combination products.
• ssist project teams in planning, preparation, review and approval of quality documentation. Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and / or combination products including compliance with Corporate policies, processes and procedures.
• pply effective quality systems, procedures and / or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
• Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
• Support new product introduction for pharmaceutical products, medical devices, or combination products.
• Support design changes to existing medical devices and combination products.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Oversee the implementation and management of training and education programs for various aspects of quality assurance.

Requirements :