Position Overview
Summary :
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 : 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.
Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO , GMP, CFR Part ).
Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify...