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Quality Assurance Specialist

4 weeks ago

Houston, Texas, United States Healgen Scientific Limited Full time
Job Description

The Quality Assurance Specialist will play a critical role in ensuring compliance with FDA guidelines and ISO 13485 regulations. The ideal candidate will have a strong understanding of quality standards and be able to develop, implement, and maintain quality assurance processes and systems.

Key Responsibilities:

  • Work with cross-functional teams to ensure compliance with regulatory requirements.
  • Support investigations and root cause analyses.
  • Facilitate document control and change control processes.
  • Coordinate with process owners to update procedures and draft documentation.
  • Ensure completed documentation meets internal quality standards.

Requirements:

  • At least 2 years of relevant experience and a relevant bachelor's degree OR at least 5 years of relevant experience without a degree.
  • Strong understanding of FDA guidelines and ISO 13485 regulations.
  • Ability to work with cross-functional teams and communicate effectively in written and spoken English.
  • Ability to troubleshoot and prioritize tasks effectively.

Please note that this position will be onsite.