Quality Assurance Engineer

hace 2 semanas


Ciudad de México, Ciudad de México Healthcare Businesswomen's Association A tiempo completo

Job Title: Quality Assurance Engineer

Job Summary: We are seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for independently setting quality standards, developing methods for testing and sampling, and evaluating production processes to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement quality control procedures to ensure product quality and compliance with regulatory requirements.
  • Conduct audits and inspections to identify areas for improvement and implement corrective actions.
  • Collaborate with cross-functional teams to develop and implement quality management systems.
  • Provide training and coaching to team members on quality procedures and best practices.
  • Lead investigations of product and process non-conformances and develop effective corrective and preventive actions.

Requirements:

  • Bachelor's degree in Engineering, Science, or related field.
  • At least 4 years of experience in quality assurance or a related field.
  • Knowledge of quality management systems, including ISO 13485 and 21 CFR 820.
  • Excellent communication and problem-solving skills.

Preferred Qualifications:

  • Master's degree in Engineering or related field.
  • Experience with Six Sigma or Lean methodologies.
  • Knowledge of medical device regulations and standards.


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