You will initiate, document, and assist with Non-Conformance (NC) investigations by identifying quality issues, gathering relevant information, and supporting corrective and preventive actions.
Own and control the Design History File for each product line — design plans, inputs, outputs, reviews, traceability matrices to ensure completeness and compliance with ISO 13485.
Standardize Procedures: Maintain and update current equipment maintenance, troubleshooting, and calibration procedures and work instructions to ensure ongoing consistency.
Optimizing manufacturing drawings with regard to the definition of quality requirements, particularly taking into account technical feasibility and reasonable tolerances
Optimizing manufacturing drawings with regard to the definition of quality requirements, particularly taking into account technical feasibility and reasonable tolerances