Quality Assurance Specialist

hace 1 semana

Xico, México Abbott Laboratories A tiempo completo

About Abbott Laboratories

Abbott Laboratories is a global leader in the healthcare industry, dedicated to advancing medical technologies and improving people's lives. Our commitment to innovation and quality has earned us a reputation as a trusted partner in the healthcare community.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team in Querétaro, Mexico. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes, and contributing to our mission of improving healthcare outcomes.

Key Responsibilities

  • Provide independent evaluation of materials, components, products, and work processes within the Quality System.
  • Provide technical assistance to support efforts ensuring the quality of the product.
  • Assist the Engineering team in validations, testing, and troubleshooting processes to improve processes and product.
  • Ensure proper performance of tasks from other peers.

Requirements

  • Ensure compliance with Corporate and Divisional Policies and Procedures.
  • Review material, equipment, and systems quality through examination, inspection, measurement, or testing of raw materials, components, subassemblies, packaging, labeling, and documentation.
  • Verify and audit processes to prevent Quality System and Manufacturing impact.
  • Review and verify compliance of quality and manufacturing documentation.
  • Execute quality testing of samples as part of daily activities with minimal guidance.
  • Identify and segregate nonconforming material from the production line and coordinate with Quality Engineer.
  • Propose and execute product acceptance testing, sampling, inspection, classification, or disposal.
  • Perform root cause analysis and provide corrections, preventive, and corrective actions to assigned nonconformances.
  • Assist Engineering team in providing manufacturing support by reviewing and analyzing data.
  • Perform data compilation and analysis to determine process behaviors, trends, and improvement opportunities.
  • Resolve and prevent manufacturing issues by assisting the Engineering team in determining root cause and implementing corrective actions.
  • Develop and implement process improvements by assisting Engineering team in researching and validating changes.
  • Troubleshoot and provide inputs to engineering, qualification, and validation studies.
  • Execute validation activities defined by protocols.
  • Prepare quality data for Functional Team, cross-site meetings, and monthly Quality Reports.
  • Assist in the writing of Build at Risk (BAR's) and its approval process.
  • Support readiness activities for audits.
  • Assist operations on electronic DHR clarification or doubts.
  • Final product release before and after sterilization.
  • Support manufacturing lines with clarification of documental doubts and correction of documentation errors.

Education and Experience

  • Technical career.
  • 4 years of experience as a Quality Technician or related areas.
  • Knowledge of technical concepts and processes.
  • Experience in reading and analyzing numerical and statistical data.
  • Knowledge of Quality Systems/Engineering required.
  • Statistical knowledge including statistical software such as Minitab, JMP.
  • Previous experience in validations, qualifications, or test methods.
  • Knowledge in blueprint reading and experience with sampling techniques.
  • Excellent interpersonal and communication skills.
  • Certified Quality Technician (CQT) or Certified Quality Engineer (CQE).
  • Intermediate English Level.

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