Senior Qa Design Transfer Engineer I - Pearland, Tx

992

Pearland, TX, US
Not specified; not specified; benefits include med...
Onsite
21 cfr 820 quality systems medical devices
Iso 13485 regulatory standards knowledge
Design control from inputs to outputs
The role involves guiding the design team as a subject matter expert on Design Control from inputs through outputs and process validation

Job Summary

  • The role involves guiding the design team as a subject matter expert on Design Control from inputs through outputs and process validation.
  • Employees are responsible for coordinating risk analysis activities, leading meetings, and ensuring risk mitigation strategies are implemented.
  • Merit Medical offers benefits including multiple shift options, onsite medical clinics, cafeterias, and a 401K with Health Savings Account.

Matching Summary

The role involves guiding the design team as a subject matter expert on Design Control from inputs through outputs and process validation.

Salary

Not specified; Not specified; Benefits include medical/dental insurance, onsite clinic, vacation, sick-time, and 401K

Skills & Requirements

Must-have

  • 21 CFR 820 Quality Systems Medical Devices
  • ISO 13485 regulatory standards knowledge
  • Design control from inputs to outputs
  • Risk analysis and management leadership
  • Engineering Change Notification (ECN) generation
  • Root cause investigation and corrective actions

Nice-to-have

  • Mentoring engineers and technicians
  • Experience with Minitab or JMP software
  • Oracle database familiarity
  • ASQ Certified Quality Engineering exam
  • Lean manufacturing and Six Sigma tools
  • Supplier audit support experience

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • Minimum of eight years of engineering experience
  • Demonstrated working knowledge of ISO 14791
  • Passed ASQ Certified Quality Engineering exam preferred

Work Rights

Not specified

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