Quality Manager
Medline Industries, Inc.
Mexicali, Mexico
hace 23 días

Objective :

Ensure that the company's quality system is in compliance with the regulations of FDA, ISO and Canadian Regulations.

Main Responsibilities :

  • Ensure that manufactured products meet specifications.
  • Ensure that manufacturing methods as well as inspections comply with procedures and regulations.
  • Maintain control of the DHR.
  • Maintain the quality system documentation system.
  • Maintain the evidence of the training of the personnel involved in the quality system.
  • Ensure through the receipt inspection that the components are in accordance with specifications.
  • Maintain the process statistics to measure the effectiveness of the process according to the quality objectives.
  • Verification of the manufacturing equipment that is operating within the authorized parameters through validations.
  • Ensure that the clean room environment complies with the authorized operating parameters.
  • Communicate all customer complaints related to the quality system.
  • Investigate customer complaints to get to the root of the problem and take preventive actions.
  • Maintain a process of communication and corrective actions with the suppliers of components as well as services through the SCARs.
  • Maintain an effective control plan for insects and rodents.
  • Qualifications

    REQUIREMENTS : Education : Bachelor’s degree on industrial Engineering Experience :

  • At least three years in the area of quality control in medical products
  • Technical skills :

  • Bilingual (English - Spanish) spoken and written
  • Knowledge of FDA / ISO regulations
  • Interpersonal skills :
  • Leadership
  • Leadership
  • Effective communication
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