Quality Assurance Validation Specialist

2 weeks ago


Austin, Texas, United States Novozen Healthcare LLC Full time

Position Title: Validation Engineer

Key Responsibilities:

  • Support engineering, manufacturing, logistics, and quality teams in validation activities for equipment.
  • Document findings and communicate solutions effectively to both internal and external stakeholders.
  • Create necessary validation documentation as required.
  • Execute validation tasks associated with designated projects.
  • Facilitate process enhancements and implement controls for specific projects.
  • Work collaboratively with program managers to schedule and carry out validations for assigned initiatives.

Required Qualifications:

  • Bachelor's degree in Engineering or a related technical discipline.
  • A minimum of 5 years of experience in engineering or quality assurance roles.
  • Familiarity with standards and submissions in the medical industry.
  • Assist the validation team with all essential quality and validation tasks for assigned equipment.
  • Contribute to the development and execution of comprehensive validation plans.
  • Prepare and implement the Design of Experiments (DOE) Matrix and execute processes accordingly.
  • Analyze data and optimize key parameters based on inspection outcomes.
  • Conduct process optimization trials.
  • Prepare and review reports on process development and engineering studies.
  • Develop, approve, execute, and monitor Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) protocols.
  • Review documentation as needed and coordinate corrective actions to address issues.

Additional Qualifications:

  • Excellent verbal and written communication skills.
  • Knowledge of FDA 21 CFR, 21 CFR Part 11, and ISO 13485 regulations.
  • Ability to collaborate effectively within teams.
  • Six Sigma Green Belt certification is preferred.
  • Experience in Quality Management System (QMS) implementation.
  • Background in manufacturing medical industry components.


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