Quality Engineer

Envista

Mahwah, NJ, US
Base: $80,300 - $95,000; bonus/equity: annual perf...
Hybrid
Bachelor's degree in engineering or quality discipline
Minimum three years experience in medical device validation
Knowledge of iso 13485 and fda requirements
The Quality Engineer ensures compliance with Nobel Biocare Quality Management System and FDA/ISO 13845 requirements

Job Summary

  • The Quality Engineer ensures compliance with Nobel Biocare Quality Management System and FDA/ISO 13845 requirements.
  • Responsibilities include leading CAPA investigations, overseeing production audits, and driving continuous improvement across manufacturing processes.
  • This full-time onsite position requires a candidate residing within commuting distance of Mahwah, NJ.

Matching Summary

The Quality Engineer ensures compliance with Nobel Biocare Quality Management System and FDA/ISO 13845 requirements.

Salary

Base: $80,300 - $95,000; Bonus/Equity: Annual performance bonus possible; Benefits: Medical/dental/vision, 401K match included

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or quality discipline
  • Minimum three years experience in medical device validation
  • Knowledge of ISO 13485 and FDA requirements
  • Experience with CAPA investigations and non-conformance resolution
  • Ability to travel domestically or internationally as needed

Nice-to-have

  • Working knowledge of CNC milling processes
  • Experience in dental lab operations or prosthetic workflows
  • Proficiency with Minitab statistical software
  • Understanding of glass, ceramics, or zirconia materials
  • Strong interpersonal and cross-functional collaboration skills

Key Requirements

  • Bachelor's of Science in engineering, technical, or quality discipline
  • Minimum three (3) years of relevant engineering or testing experience
  • Must reside within commutable distance to Mahwah, NJ

Work Rights

Not specified

Tailored Resume

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