Quality Engineer II

Main Responsibilities

• Creates, manages and improves the Master Validation Plan
• Designs protocols that utilize proper sampling techniques, strong design of experiments and tests and provides statistical rationale
• Conducts validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards
• Conducts sterilization validations in accordance with internal protocols and external standards
• Supports activities related to the master sterilization plan
• Develops and manages aging studies for packaging which may include coordinating testing, analyzing data and documenting results
• Leverages various software programs such as Word, Excel, SAP, Minitab and other necessary programs or project tools to manage and analyze data and complete work
• Provides analysis and interpretation of report data including the use of systems
• Leads Risk Analysis
• Responsible for KPI improvement on the production floor
• SME for Change Control
• Performs additional duties as directed

  Requirements

  • Bachelor’s degree (B.S.) in Engineering or other technical degree from a four-year college or university is required
  • Four to six years of experience in the Quality field is required
  • Three to five years of experience in a manufacturing environment preferred
  • Green/Black Belt Certification or Lean Manufacturing training preferred
  • Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred