Staff Microbiology Specialist

J&J FAMILY OF COMPANIES

Santa Clara, California, United States of America
$109,000.00 - $174,800.00; not specified; not spec...
Hybrid
Microbiology and sterilization validation
Sterile barrier and packaging controls
Microbiology test criteria
Johnson & Johnson is seeking a Staff Microbiology Specialist for their Shockwave Medical team in Santa Clara, CA, focusing on quality assurance and microbiology aspects of medical device design. The ideal candidate will have extensive experience in the medical device industry, particularly in quality control, sterilization validation, and microbiology testing

Job Summary

  • The Staff Microbiology Specialist provides Quality Assurance support with a focus on Microbiology aspects for sustaining and design control activities.
  • Essential job functions include leading microbiology and sterilization related activities, performing assessments of sterile barrier and packaging controls, and identifying appropriate microbiology test criteria.
  • The role requires a Bachelor of Science degree in Biology, 7+ years of hands-on progressive experience in Quality within the Medical Device industry, and working knowledge of applicable medical device regulations.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Staff Microbiology Specialist for their Shockwave Medical team in Santa Clara, CA, focusing on quality assurance and microbiology aspects of medical device design. The ideal candidate will have extensive experience in the medical device industry, particularly in quality control, sterilization validation, and microbiology testing.

Salary

$109,000.00 - $174,800.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Microbiology and Sterilization validation
  • Sterile barrier and packaging controls
  • Microbiology test criteria
  • Supplier qualification and testing
  • Microbiology audits
  • Quality Management System

Nice-to-have

  • Cross-functional team collaboration
  • Problem-solving and risk analysis
  • Data analysis and trend identification
  • Continuous improvement of QMS

Key Requirements

  • Bachelor of Science degree in Biology
  • 7+ years of experience in Medical Device Quality
  • Working knowledge of medical device regulations
  • Experience with sterilization validation
  • Experience with microbiology testing
  • Experience with Design Verification and Validation
  • Experience with Hazard/Risk Analysis
  • Experience with FDA GMP

Work Rights

Not specified

Tailored Resume

Cover Letter