Senior Quality Engineer

West Glens Falls, NY, US • Posted 3 days ago • Updated 3 days ago
Contract Independent
Contract W2
6 Months
No Travel Required
On-site
Depends on Experience
Fitment

Dice Job Match Score™

⏳ Almost there, hang tight...

Job Details

Skills

  • PFMEA
  • Minitab
  • Component
  • QMS

Summary

Responsibilities:

  • Support production line transfers and ensure compliance with quality standards
  • Lead component qualification and test method validation
  • Collaborate with cross-functional teams to find creative, compliant solutions
  • Support product launch & initial manufacturing operations
  • Maintain and update documentation per internal Quality Policies & FDA/GMP guidelines
  • Conduct failure analysis and assist in resolving manufacturing issues during process development
  • Provide data-driven input on technical issues and projects

Qualifications:

  • Experience: 3–10 years in medical device or pharmaceutical industry (regulated environment required)
  • Education: BS/BA in Chemical, Biochemical, Mechanical, Electrical, Industrial Engineering, Biological Sciences, Chemistry, or related field
  • Regulatory Knowledge: Working understanding of GMP, ISO, FDA Quality Systems Regulations
  • Technical Skills: PFMEAcreation, Component qualification activities, Test method development & validation, Failure analysis & root cause investigation, Statistical methods & software (Minitab, JMP, etc.)
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: 90806069
  • Position Id: 9044561
  • Posted 3 days ago
Contact the job poster
SG

Subhajit Ghosh

Recruiter @ SOHO Square Solutions
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