Senior Quality Engineer - Design Assurance

Mammotome

Cincinnati, Ohio, United States
$100,000 to $120,000; bonus/incentive pyy eligible...
Design control activities
Risk management activities
Iso 14971 principles
Serve as the Design Quality Lead during all stages of design controls projects, supporting user needs, product requirements, design specifications, and verification/validation strategies

Job Summary

  • Serve as the Design Quality Lead during all stages of design controls projects, supporting user needs, product requirements, design specifications, and verification/validation strategies.
  • Generate and independently maintain project risk management files for NPD and sustaining projects, including risk plans, FMEAs, and effectiveness checks using ISO 14971 principles.
  • Author updates to corporate quality procedures in response to new standards or regulatory requirements to ensure QMS compliance and efficiency.

Matching Summary

Serve as the Design Quality Lead during all stages of design controls projects, supporting user needs, product requirements, design specifications, and verification/validation strategies.

Salary

$100,000 to $120,000; Bonus/incentive pay eligible; Comprehensive benefits package

Skills & Requirements

Must-have

  • Design Control activities
  • Risk Management activities
  • ISO 14971 principles
  • 21 CFR 820
  • ISO 13485
  • Medical device industry experience

Nice-to-have

  • Continuous improvement culture
  • Collaborative team environment
  • Passion for patient care
  • Leading external audits
  • Non-product software validation
  • Professional Certification

Key Requirements

  • Bachelor's degree in engineering
  • Minimum 5 years engineering experience
  • Comprehensive knowledge of medical device regulations
  • Strong knowledge of design control principles
  • Knowledge of process validation

Work Rights

Not specified

Tailored Resume

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