Validation Engineer

Summary:
Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices.

Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.

Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.

Roles & Responsibilities:

Lead, Develop and execute validation activities for CNC machines (, mills, lathes, multi-axis CNCs) and associated tooling/work holding.

Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.

Proficiency in developing and executing IQ/OQ/PQ protocols.

Experience with metrology, calibration, and measurement system analysis.

Knowledge of CNC machines, CAM software, and basic CNC programming concepts.

Statistical ...