Position Summary

The Senior Quality Engineer is responsible for supporting New Product Introduction (NPI), product transfers, and process validation, while contributing to the development and continuous improvement of the Quality Management System (QMS). This role provides leadership in the definition, implementation, and improvement of quality practices, and serves as a key technical resource in validation, risk management, and manufacturing quality within a fast-paced, startup environment.

Responsibilities

• Lead and/or support product transfers and NPI activities, ensuring compliance with customer and regulatory requirements
• Develop, execute and/or collaborate in process validation strategies (IQ/OQ/PQ) for new and transferred processes
• Drive risk management activities, including PFMEA and control plan development
• Define inspection strategies, sampling plans, and acceptance criteria aligned with product risk and reg...