Quality Engineer, Staff

Confluent Medical Technologies

Laguna Niguel, CA, US
$90,800.00 - $151,300.00 py
On-site
Design control requirements
Risk management files
Statistical data analysis
Confluent Medical Technologies is seeking a Staff Quality Engineer to ensure compliance with customer, risk management, and quality requirements in the design and development of medical devices. This role involves working on complex projects and requires extensive experience in quality assurance within the medical device industry

Job Summary

  • Ensure compliance to customer, risk management, quality, and design control requirements in design and development projects.
  • Responsible for generating and maintaining risk management files supporting product development projects.
  • Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements and process capability analysis.

Matching Summary

Match Score: 85

Confluent Medical Technologies is seeking a Staff Quality Engineer to ensure compliance with customer, risk management, and quality requirements in the design and development of medical devices. This role involves working on complex projects and requires extensive experience in quality assurance within the medical device industry.

Salary

$90,800.00 - $151,300.00

Skills & Requirements

Must-have

  • Design control requirements
  • Risk management files
  • Statistical data analysis
  • Process validation protocols
  • FDA, ISO 13485, EU MDR

Nice-to-have

  • Innovative material science
  • Customer collaboration
  • Problem-solving skills

Key Requirements

  • 5+ years experience in Medical Device Product Development
  • 5+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements
  • BS in engineering discipline and 5 years experience or MS and 4 years experience
  • Strong statistical data analysis skills using Minitab

Work Rights

Not specified

Tailored Resume

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