Quality Assurance Specialist

hace 3 semanas


Alajuela, Alajuela, Costa Rica MicroVention A tiempo completo

Job Summary:

The Quality Technician II provides critical support to the quality reliability team by ensuring finished products meet 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, adhere to quality management system processes and requirements, and demonstrate ethics and integrity in all matters and at all levels throughout the organization.
  • Perform bacterial endotoxin sampling and testing.
  • Perform and support clean room monitoring and validation activities, including microbial, particulate, and pressure differential testing.
  • Coordinate microbiological testing performed in-house and by outside laboratories to support routine and validation studies.
  • Support technical justifications and physical studies for adoption of new products into existing sterilization cycles, including sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
  • Perform complex mechanical, dimensional, 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 regarding validations and transfers projects.
  • Provide support on non-conformance investigation and correction implementation 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 the QC, production operators, and RI inspectors.
  • Notify quality engineering in the event of a nonconformance, noncompliance situation.
  • Perform additional duties as assigned.

About MicroVention:

MicroVention is a leading company in the field of quality assurance and reliability engineering. Our team is dedicated to ensuring the highest quality standards in our products and services.



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