Quality Assurance Specialist

hace 4 semanas


Alajuela, Alajuela, Costa Rica Microvention A tiempo completo

Job Summary

The Quality Technician II provides essential support to the quality reliability team at Microvention by ensuring finished products meet the established quality standards and worldwide regulatory requirements. This position requires the ability to handle a diverse set of projects and tasks.

Key Responsibilities

  • Comply with applicable laws and regulations and adhere to Quality Management System processes and requirements.
  • Demonstrate ethics and integrity in all matters and at all levels throughout the organization.
  • Perform bacterial endotoxin sampling and testing.
  • Support clean room monitoring and validation activities, including microbial, particulate, and pressure differential testing.
  • Coordinate microbiological testing performed in-house and by outside laboratories.
  • Support technical justifications and physical studies for adoption of new products into existing sterilization cycles.
  • Perform complex mechanical, dimensional, and microbial assessments on raw materials, products/subassemblies, and finished goods.
  • Provide guidance on sterilization control and sterile load release function.
  • Support Quality Reliability Engineering and Operations in validations and transfers projects.
  • Investigate and correct non-conformances as required.
  • Perform document updates as necessary.
  • Support Quality Reliability Engineering and Operations in the development and execution of internal test methods and validations.
  • Provide leadership and training to QC, Production Operators, and RI inspectors.
  • Notify Quality Engineering in the event of a nonconformance or noncompliance situation.

Requirements

The successful candidate will have a strong understanding of quality management systems, microbiology, and sterilization processes.



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