Senior Quality Engineer - Design Assurance

Danaher UK

Cincinnati, Ohio, United States
Base: $100,000 to $120,000; bonus/equity: eligible...
Onsite
5 years medical device engineering experience
Iso 14971 risk management application
21 cfr 820 and iso 13485 compliance knowledge
Danaher UK is seeking a Senior Quality Engineer for Design Assurance to join its Mammotome division in Cincinnati, Ohio. The role involves ensuring product compliance and collaborating with cross-functional teams to maintain adherence to quality management systems, particularly in the medical device industry

Job Summary

  • The Senior Engineer supports Design Control and Risk Management activities to bring new products to market while ensuring compliance with international standards.
  • This role involves generating and maintaining project risk management files using ISO 14971 principles for both new product development and sustaining projects.
  • The position offers a competitive salary range of $100,000 to $120,000 along with comprehensive benefits including medical insurance and 401(k) matching.

Matching Summary

Match Score: 85

Danaher UK is seeking a Senior Quality Engineer for Design Assurance to join its Mammotome division in Cincinnati, Ohio. The role involves ensuring product compliance and collaborating with cross-functional teams to maintain adherence to quality management systems, particularly in the medical device industry.

Salary

Base: $100,000 to $120,000; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Paid time off, medical/dental/vision insurance, 401(k)

Skills & Requirements

Must-have

  • 5 years medical device engineering experience
  • ISO 14971 risk management application
  • 21 CFR 820 and ISO 13485 compliance knowledge
  • Design verification and validation strategies
  • FDA, ISO, and MDSAP audit support

Nice-to-have

  • Leading external audits with Notified Bodies
  • Non-product software validation experience
  • Certified Quality Engineer or Six Sigma certification
  • Collaborative high-performing team culture

Key Requirements

  • Bachelor's degree in engineering from accredited college
  • Minimum 5 years experience in medical device industry
  • Valid driver's license with acceptable driving record

Work Rights

Not specified

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