Principal Design Quality Engineer

Fresenius Medical Care

Base: $117,000 - $196,000 annually; bonus/equity: ...
Design history file reviews
Fda and iso regulatory compliance
Risk management and test method validation
The role requires a seasoned professional to ensure design control projects comply with FDA and ISO requirements while managing the New Product Development process

Job Summary

  • The role requires a seasoned professional to ensure design control projects comply with FDA and ISO requirements while managing the New Product Development process.
  • Responsibilities include acting as a subject matter expert on risk management, test method validation, and statistics to resolve complex engineering issues.
  • The position offers a comprehensive benefits package including medical, dental, vision insurance, a 401(k) match, and potential performance-based bonuses.

Matching Summary

The role requires a seasoned professional to ensure design control projects comply with FDA and ISO requirements while managing the New Product Development process.

Salary

Base: $117,000 - $196,000 annually; Bonus/Equity: Potential for performance-based bonuses; Benefits: Medical, dental, vision, 401(k) match, paid time off, parental leave

Skills & Requirements

Must-have

  • Design History File reviews
  • FDA and ISO regulatory compliance
  • Risk Management and Test Method Validation
  • Process Validation expertise
  • Design verification and validation

Nice-to-have

  • Mentorship of junior staff
  • Cross-functional project leadership
  • Fast-paced environment adaptability
  • Strong presentation skills

Key Requirements

  • Bachelor's degree required; Master's preferred
  • 8-12+ years experience or 6+ with Master's
  • Deep knowledge of Design History Files
  • Experience with FDA and ISO audits

Work Rights

Not specified

Tailored Resume

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