Quality Engineer Ii

Abbott

Westfield, Indiana, United States
Base: $61,300.00 – $122,700.00; bonus/equity: not ...
Not specified (assumed to be office-based due to the nature of the role).
Bachelor's degree in engineering
2-5 years of engineering experience
Knowledge of fda gmp iso standards
Abbott is seeking a Quality Engineer II for its Structural Heart Division in Westfield, Indiana. The role involves quality engineering support for product development and manufacturing, focusing on process optimization and compliance with regulatory standards

Job Summary

  • This position is responsible for developing and maintaining quality engineering methodologies within the Structural Heart Division to support new product development and manufacturing.
  • The role requires leading the investigation, resolution, and prevention of product non-conformances while ensuring compliance with FDA regulations and ISO standards.
  • Abbott offers comprehensive benefits including free medical coverage options, a high employer contribution retirement plan, and tuition reimbursement programs.

Matching Summary

Match Score: 85

Abbott is seeking a Quality Engineer II for its Structural Heart Division in Westfield, Indiana. The role involves quality engineering support for product development and manufacturing, focusing on process optimization and compliance with regulatory standards.

Salary

Base: $61,300.00 – $122,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 2-5 years of engineering experience
  • Knowledge of FDA GMP ISO standards
  • Process control system implementation
  • CAPA system management

Nice-to-have

  • Medical device industry experience
  • Six Sigma and Lean Manufacturing expertise
  • ASQ CQE certification
  • Cross-functional team leadership
  • Statistical data analysis skills

Key Requirements

  • Bachelors Degree in Engineering or related field
  • 2–5 years of engineering experience
  • Strong knowledge of FDA, GMP, ISO 13485, and ISO 14971
  • Medical device experience preferred
  • Six Sigma, Lean Manufacturing, and ASQ CQE certification a plus

Work Rights

Not specified

Tailored Resume

Cover Letter