Design Quality Engineer I, Lifecycle

Abiomed

Aachen, North Rhine-Westphalia, Germany
Base: 51.200 to 80.845 eur; bonus/equity: not spec...
Design controls
Risk management
Fda qmsr
The Design Quality Engineer will perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products, including risk management, design verification, design validation, and design assurance activities

Job Summary

  • The Design Quality Engineer will perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products, including risk management, design verification, design validation, and design assurance activities.
  • This role's emphasis will be in support of Abiomed’s existing single-use heart pumps, ensuring compliance with FDA QMSR, ISO 13485, and other national and international quality and regulatory requirements.
  • Abiomed is an innovative medical device company with an inspiring mission of “Patients First” and a unique guiding principle of “Recover Hearts. Saving Lives.”

Matching Summary

The Design Quality Engineer will perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products, including risk management, design verification, design validation, and design assurance activities.

Salary

Base: 51.200 to 80.845 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Design Controls
  • Risk Management
  • FDA QMSR
  • ISO 13485
  • Data Gathering and Analysis
  • Quality Management Systems (QMS)

Nice-to-have

  • Agility
  • Disruptive Innovations
  • Execution Focus
  • Continuous Improvement
  • Business Behavior

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • 0 - 2 years of quality experience
  • Experience in the medical device industry
  • Masters desired

Work Rights

Not specified

Tailored Resume

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