Regional Lead Quality Engineer

Century Center

Base: $143,000 - $169,000; bonus/equity: incentive...
5 years medical device experience
Design control process expertise
21 cfr part 4 compliance knowledge
The role leads a regional team to ensure new product development activities comply with FDA and EU MDR regulations

Job Summary

  • The role leads a regional team to ensure new product development activities comply with FDA and EU MDR regulations.
  • Candidates must possess at least 5 years of experience in quality or manufacturing within the medical device field.
  • Total compensation includes base salary ranging from $143,000 to $169,000 plus potential incentive compensation and equity.

Matching Summary

The role leads a regional team to ensure new product development activities comply with FDA and EU MDR regulations.

Salary

Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified

Skills & Requirements

Must-have

  • 5 years medical device experience
  • Design Control process expertise
  • 21 CFR Part 4 compliance knowledge
  • ISO 13485 and ISO 14971 application
  • Vendor management and audit skills
  • Six Sigma problem solving techniques

Nice-to-have

  • Experience with drug-delivery products
  • Knowledge of embedded software systems
  • Connected health solutions background
  • Strong stakeholder influence skills
  • International travel availability

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • Minimum 5 years relevant industry experience
  • Practical experience in R&D Quality and design controls

Work Rights

Not specified

Tailored Resume

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