6001 - Project Engineer / Risk Management (pharma/med Device)

Verista

Indianapolis, IN, US
$80,465—$114,429 usd; not specified; medical, dent...
On-site
Iso 14971 risk management
Fmea creation and review
Turbo ac software system sme
Support the creation and continuous improvement of risk management deliverables aligned with ISO 14971

Job Summary

  • Support the creation and continuous improvement of risk management deliverables aligned with ISO 14971.
  • Facilitate the migration of FMEAs from existing software into the Turbo AC system and serve as a subject matter expert.
  • Collaborate with cross-functional teams including engineering, manufacturing, quality, and human factors to ensure accurate FMEA setup.

Matching Summary

Support the creation and continuous improvement of risk management deliverables aligned with ISO 14971.

Salary

$80,465—$114,429 USD; Not specified; Medical, Dental & Vision insurances

Skills & Requirements

Must-have

  • ISO 14971 risk management
  • FMEA creation and review
  • Turbo AC Software System SME
  • Cross-functional collaboration

Nice-to-have

  • TurboAC or QMSpace experience
  • FDA and EU MDR design control
  • Change Control Trackwise or Veeva OneQMS

Key Requirements

  • Bachelor's degree in engineering, biomedical, or related field
  • 3-5 years of experience in medical device development or risk management
  • Knowledge of ISO 14971
  • Proficiency with Microsoft Office tools

Work Rights

Not specified

Tailored Resume

Cover Letter