Quality Engineer

Job description

Company Description Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. We leverage a long-standing experience to provide our clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing. Overview: Responsibilities: - Ensures compliance with applicable standards and regulatory requirements (e.g., FDA, ISO) - Manages manufacturing quality operations supporting the production lifecycle (e.g., DHR, batch release, risk-based controls) - Supports additional quality activities such as design controls, risk management, verification and validation, design changes, and design transfer - Develops and utilizes quality tools within the Chicago Innovation Center - Supports the development and implementation and improvement of the Quality Management System (QMS) - Works within established procedures covering quality, environmental health and safety, confidentiality and good manufacturing practices - Supports and challenges project team on all aspects of quality - Reviews and approves quality documented in accordance with d...