Quality Engineer
Alajuela, Costa Rica
hace 11 días

JOB DESCRIPTION : Essential Functions :

Essential Functions :

  • Provides Quality Engineering Body of Knowledge support to company and organization.
  • Verify company’s adherence to the established Quality System and GMP / ISO standards.
  • Work with Engineering, Manufacturing, Laboratories and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required accomplishing quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports, typically with mentorship from higher level engineering.
  • Perform tests according to various protocol requirements.
  • Assist in completion of risk management and risk analysis including FMEA.
  • Assist in completion of customer complaint related investigations.
  • Work with R&D to devise design verification and design validation plans for products based on performance specifications and risk analysis.
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning optimization and compliance to specification.
  • Assist in measuring process capability, process controls, and process validation. Assist in definition of CTQ parameters.
  • Aide in definition of sampling plans and inspection methods.
  • Assist in specifications and testing of sterilization methods.
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
  • Perform other duties and responsibilities as assigned by senior management.
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