Quality Engineer Ii

Abbott

Westfield, Indiana, United States
Base: $61,300.00 – $122,700.00; bonus/equity: not ...
Fda regulations compliance
Gmp and iso 13485 knowledge
Six sigma and lean manufacturing
This position is responsible for developing and maintaining quality engineering methodologies to support new product development and manufacturing within the Structural Heart Division

Job Summary

  • This position is responsible for developing and maintaining quality engineering methodologies to support new product development and manufacturing within the Structural Heart Division.
  • The role requires leading investigations into product non-conformances and implementing process controls to meet FDA and ISO regulatory requirements.
  • Abbott offers comprehensive benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement programs.

Matching Summary

This position is responsible for developing and maintaining quality engineering methodologies to support new product development and manufacturing within the Structural Heart Division.

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

  • FDA regulations compliance
  • GMP and ISO 13485 knowledge
  • Six Sigma and Lean Manufacturing
  • Process control system development
  • CAPA system implementation

Nice-to-have

  • ASQ CQE certification preferred
  • Medical device industry experience
  • Cross-functional team leadership
  • Statistical data analysis skills

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 2–5 years of engineering experience
  • Strong knowledge of ISO 14971 standards

Work Rights

Not specified

Tailored Resume

Cover Letter