Quality Engineer (Medical / Pharma background)
Creative Solutions Services, LLC - Santa Rosa, CA

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Quality Engineer

Job Description:
  • Completes Design History File documentation
  • Creates and delivers presentations throughout the organization
  • Design of Experiments (DOE) and Statistical Process Control (SPC)
  • Determines manufacturing operation requirements and process parameters
  • Develops advanced manufacturing systems and processes
  • Develops and implements strategic plans
  • Develops plans to evaluate process repeatability and stability
  • Develops product and process improvements
  • Participates in procedure writing and review
  • Performs process and equipment validations
  • Provides technical support to other engineers
  • Supports manufacturing, development, and implementation processes
  • Utilizes FMEA within process development
  • Ensures compliance with GMP’s
  • Generates documentation for engineering protocols and reports
  • Writes engineering and manufacturing specifications
Skills: Education Level: Undergraduate Degree Good Oral Communication Good Written Communication and legible handwriting Excellent Facilitation Skills Travel: 10-25% TravelTools, Software and Experience with: - CAD Systems: AutoCAD - Pro Engineer - Solidworks - Certifications/ Engineering: ASQC - Design Controls, DHF, and Engineering Documentation - PE - Professional Engineer - QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance Preferred Skills: Development Tools: MS Windows CE Education Level: Graduate Degree (Master of Science) Interviewing Skills

About this company
There's no mystery behind how Black Box does business. The company distributes and supports voice and data networking infrastructure....