MAIN RESPONSIBILITIES
Existing Product Quality Management
Ensure the proper application of all current procedures and standards to guarantee continuous product quality system conformity, from raw material reception and manufacturing to market distribution;Monitor and analyze quality performance indicators for existing products (RMA, customer returns, production efficiency) and conduct trend analyses to support continuous improvement for assigned products;Lead the product risk management process and maintain updated risk analysis files in accordance with ISO 14971 in response to post-market or production data, or following design or manufacturing process change requests;Actively participate in the evaluation of modification requests (ECOs) to ensure product quality, safety, reliability, performance, or conformity;Review and approve test plans and reports necessary for product verification and validation during change requ...