Sr Design Quality Engineer – Medical Devices

Cardinal Health

Base: $68,500 - $97,800; bonus/equity: no bonus el...
Hybrid
Bachelor's degree in engineering or related field
Knowledge of iso 14971 and iso 13485 standards
Experience with design verification and validation processes
This role drives quality excellence throughout the design and development life cycle of medical devices by ensuring robust design control processes

Job Summary

  • This role drives quality excellence throughout the design and development life cycle of medical devices by ensuring robust design control processes.
  • The position requires developing and maintaining risk management files across a broad set of technologies to ensure continued product acceptability.
  • Cardinal Health offers a comprehensive benefits package including medical, dental, vision coverage, 401k savings plan, and paid time off.

Matching Summary

This role drives quality excellence throughout the design and development life cycle of medical devices by ensuring robust design control processes.

Salary

Base: $68,500 - $97,800; Bonus/Equity: No bonus eligible; Benefits: Medical, dental, vision, HSA, 401k, PTO, parental leave

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • Knowledge of ISO 14971 and ISO 13485 standards
  • Experience with design verification and validation processes
  • Proficiency in risk management file development
  • Understanding of 21CFR820 GMP regulations

Nice-to-have

  • ASQ CQE certification preferred
  • Strong technical writing skills
  • Ability to collaborate cross-functionally
  • Statistical analysis tools knowledge
  • Root cause analysis expertise

Key Requirements

  • Bachelor's degree in engineering or related field
  • 2+ years of experience in medical device design
  • ASQ CQE certification (preferred)
  • Not specified

Work Rights

Not specified

Tailored Resume

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