Quality Assurance Specialist

hace 19 horas


Oaxaca, Oaxaca, México Tecma A tiempo completo

Job Summary:

Tecma is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities:

  • Develop and implement quality plans, control plans, and risk files to ensure compliance with regulatory requirements.
  • Lead the Medical Review Board (MRB) and ensure that all quality-related issues are properly documented and addressed.
  • Collaborate with the engineering department to develop manufacturing documentation and validation documents (IQ, OQ, PQ).
  • Participate in the development of new products and coordinate Non-Purchase Work Orders (NPWOS) and Service Work Orders (SWOS).
  • Develop and implement statistical tools to analyze data and improve quality processes.
  • Manage and train quality personnel, including selection, hiring, and direction of daily activities.
  • Familiarity with CAPAs, COs, DHRs, and PFMEAs is required.

Requirements:

  • Bachelor's degree in engineering from a four-year college or university.
  • Excellent written and verbal communication skills in English and Spanish.
  • Minimum of 3-5 years of experience in a similar position.
  • Knowledge of ISO 13485 and root cause analysis tools.
  • Ability to collect and present data per established metrics.
  • Experience in developing inspection methods, establishing sampling plans, and interpreting customer specifications.

Working Conditions:

  • Full-time position.
  • 8-hour shift.
  • Types of compensation: attendance bonus and punctuality bonus.
  • Work location: In-person.


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