Senior Qa Design Transfer Engineer I - Pearland, Tx

Merit Medical Systems

Pearland, TX, US
Onsite
21 cfr 820 quality systems medical devices
Iso 13485 regulatory standards knowledge
Design control from inputs to outputs
Merit Medical Systems is seeking a Senior QA Design Transfer Engineer in Pearland, TX, who will be responsible for ensuring effective design transfer into manufacturing for innovative medical devices. The ideal candidate will have extensive experience in engineering, particularly within the medical device industry, and will contribute to quality management and risk analysis activities

Job Summary

  • The role involves guiding the design team as a subject matter expert on Design Control from inputs through outputs.
  • Merit Medical Systems is committed to creating innovative medical devices that improve lives through hard work and team effort.
  • Employees receive benefits including multiple shift options, onsite medical clinic, two cafeterias, and a 401K with Health Savings Account.

Matching Summary

Match Score: 85

Merit Medical Systems is seeking a Senior QA Design Transfer Engineer in Pearland, TX, who will be responsible for ensuring effective design transfer into manufacturing for innovative medical devices. The ideal candidate will have extensive experience in engineering, particularly within the medical device industry, and will contribute to quality management and risk analysis activities.

Skills & Requirements

Must-have

  • 21 CFR 820 Quality Systems Medical Devices
  • ISO 13485 regulatory standards knowledge
  • Design Control from inputs to outputs
  • Process validation and test method validation
  • Root cause investigation and CAPA
  • Engineering Change Notifications (ECNs)
  • Risk analysis and management activities

Nice-to-have

  • Mentoring engineers and technicians
  • Internal and supplier audit support
  • Continuous improvement techniques
  • Teamwork and conflict resolution skills
  • Written and verbal communication skills

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • Minimum of eight years of engineering experience
  • ASQ Certified Quality Engineering exam preferred
  • Experience with Minitab or JMP software
  • Knowledge of ISO 14791 standard

Work Rights

Not specified

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