Senior Manufacturing Quality Assurance Engineer

Merit Medical Systems

Unknown, Unknown, United States
Onsite
Bachelor's degree in engineering
Six years quality engineering experience
21 cfr 820 and iso 13485 knowledge
Merit Medical Systems is seeking a Senior Manufacturing Quality Assurance Engineer to provide extensive quality engineering support for medical device products and processes. The ideal candidate should possess strong quality assurance experience, knowledge of regulatory standards, and the ability to mentor and train others in the field

Job Summary

  • The role involves providing extensive quality engineering support for medical device products and processes while ensuring compliance with regulatory standards.
  • Candidates will be responsible for mentoring quality assurance employees, conducting failure investigations, and managing risk analysis documentation.
  • Merit Medical Systems offers a comprehensive benefits package including medical insurance, a 401K plan, and onsite amenities like cafeterias and a clinic.

Matching Summary

Match Score: 85

Merit Medical Systems is seeking a Senior Manufacturing Quality Assurance Engineer to provide extensive quality engineering support for medical device products and processes. The ideal candidate should possess strong quality assurance experience, knowledge of regulatory standards, and the ability to mentor and train others in the field.

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • Six years quality engineering experience
  • 21 CFR 820 and ISO 13485 knowledge
  • Statistical analysis and Six Sigma skills
  • Supplier quality audits and risk management

Nice-to-have

  • MasterControl or SmartCAPA software experience
  • Green Belt or Black Belt certification
  • Internal and supplier audit participation
  • Design and development activity support
  • Veteran hiring preference

Key Requirements

  • Bachelor's Degree in Engineering
  • Six years of quality engineering experience
  • Knowledge of 21 CFR 820 and ISO 13485
  • Working knowledge of statistical methodologies
  • Experience with MasterControl or SmartCAPA preferred

Work Rights

Not specified

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