Quality Control Training Specialist II

2 months ago

Fremont, California, United States Penumbra Full time
Job Summary

The Quality Control Training Specialist II will play a critical role in developing and executing training programs to support the stability and growth of our Quality Inspection environments. This position requires a strong understanding of GMP and Quality processes, as well as excellent project and process management skills.

Key Responsibilities
  • Develop, revise, and maintain current training programs and materials, including PowerPoint presentations, assessments, certification tests, worksheets, and job aids.
  • Train and test personnel for comprehension in inspecting medical devices per Penumbra's Quality System.
  • Provide required training on SOPs, ECOs, WIs, MQIs, and Quality System requirements to inspectors.
  • Respond to training requests identified by supervisors and managers.
  • Drive resolution of process and/or documentation issues, including origination and implementation of change requests.
  • Responsible for completion of personnel training records and training record monitoring and maintenance.
  • Resolve and respond to training issues and questions from throughout the Quality organization.
  • Recommend solutions for systemic training-related issues.
  • Communicate effectively with all levels of the organization to determine training needs.
Requirements
  • Bachelor's degree required with 3+ years of quality systems experience in a regulated device or pharmaceutical environment, plus 3+ years of learning and development or training experience.
  • Strong project and process management skills.
  • Strong verbal, written, and interpersonal communication skills.
  • Strong presentation skills.
  • Ability to independently develop content and simplify complex processes.
  • Basic math skills and proficiency with Microsoft Word, Excel, Access, and PowerPoint.
  • Strong attention to detail, organization, and teamwork skills.
  • Basic knowledge of GMP/QSR requirements.
Working Conditions

This position requires working in general office, production, and cleanroom environments. The ability to work swing shift hours of 4 pm to 12:30 am is also required.

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