Validation Engineer

San Jose, CA, US • Posted 4 days ago • Updated 9 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Documentation
  • Regulatory Compliance
  • ISO 9000
  • Collaboration
  • Continuous Improvement
  • Medical Devices
  • Injection Molding
  • IQ
  • OQ
  • PQ
  • Statistics
  • ISO 13485
  • Manufacturing
  • GMP

Summary

Summary:
In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards.

Roles & Responsibilities:
  • Develop and execute validation plans and reports.
  • Analyze data and troubleshoot process deviations.
  • Ensure compliance with FDA regulations and ISO standards.
  • Collaborate with Engineering and Quality teams to drive continuous improvement.
Required Qualifications:
  • 8+ years of validation experience in the medical device or other regulated industry.
  • Strong expertise in injection molding and plastic materials.
  • Hands-on experience with cleaning validation and contamination control.
  • Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
  • Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: e8580ced667f4883d3cb94e469266bb2
  • Posted 4 days ago
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