Katalyst CRO

Quality Engineer

Marlborough, MA, US

29 days ago
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Summary

Responsibilities

  • Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
  • Requires a bachelor's degree and 02 years of experience in the field or in a related area.
  • Has knowledge of commonly used concepts, practices, and procedures within a particular field.
  • Relies on instructions and preestablished guidelines to perform the functions of the job.
  • Works under immediate supervision.
  • Primary job functions do not typically require exercising independent judgment.
  • Typically reports to a supervisor or manager.
  • Relies on instructions and pre-established guidelines to perform job functions.
  • Works under immediate supervision, with primary job functions not typically requiring independent judgment.
  • Reports to a supervisor or manager.
  • Assists in the review and improvement of existing test method validation documentation .
  • Supports Test Method Validation Remediation .
  • Implements remediation plans to ensure test methods comply with current regulatory standards.

Requirements:

  • Requires a bachelor's degree in engineering, Quality Assurance, or a related field .
  • Required # of years' experience: 3 - 5 years.
  • Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.
  • Maintains accurate and organized records of validation activities.
  • Familiar with commonly used concepts, practices, and procedures in test method validation.
  • Proficiency in technical writing and documentation.

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