Job Description

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...

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