Quality Assurance Specialist

hace 4 semanas


Xico, México K&Amp;I Healthcare Services Llc A tiempo completo
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at K&Amp;I Healthcare Services Llc. The successful candidate will be responsible for ensuring the quality of our products and services, and will play a key role in maintaining our high standards of excellence.

Key Responsibilities
  • Develop and implement quality inspection procedures and test methods to support in-process and quality inspectors in manufacturing areas and functional testing labs.
  • Coordinate and provide training on new or modified inspection procedures to ensure seamless implementation.
  • Analyze and develop sampling plans to be used for inspection, utilizing corresponding AQL, RQL, and Cpk for attribute and variable data.
  • Conduct audits of production processes to verify compliance with quality requirements as specified in procedures and process control plans.
  • Participate in internal and external audit programs to ensure adherence to regulatory standards.
  • Support the execution of validations of new processes, test methods, equipment, or products, including IQ, OQ, PQ, and TMV.
  • Analyze defects and quality issues in production to identify trends and recommend corrective actions and/or changes to inspection criteria.
  • Conduct statistical analysis and propose solutions based on results.
  • Participate in multidisciplinary teams and projects for continuous improvement.
  • Supervise inspection resources, including quality inspectors and auditors, as required.
  • Lead multidisciplinary teams to implement improvements in manufacturing processes as required.
  • Participate in the introduction and/or transfer of products or processes to the Tijuana plant.
  • Support the investigation of customer complaints and establish improvements as required.
  • Monitor quality metrics and take action as necessary.
  • Manage the non-conforming material system, including material dispositions, support in containment actions, investigation, and corrective actions, and follow up on corrective actions to promote compliance with established activity dates.
Requirements
  • Advanced level of English proficiency.
  • More than 2 years of experience in the quality department.


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