Senior Engineer Supplier Development Quality

Abbott

Pleasanton, CA, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Hybrid
Fda gmp iso 13485 regulatory knowledge
Supplier selection and evaluation experience
Root cause analysis for non-conforming materials
Abbott is seeking a Senior Engineer Supplier Development Quality to work in their Heart Failure Division in Pleasanton, CA. The role involves supplier evaluation, material qualification, and maintaining quality engineering methodologies to meet regulatory requirements

Job Summary

  • This role supports Abbott's Heart Failure Division by managing supplier quality engineering methodologies to ensure regulatory compliance.
  • The engineer is responsible for owning Non-Conforming Material Reports, leading root cause investigations, and driving corrective actions with suppliers.
  • Candidates will benefit from a comprehensive benefits package including free medical coverage, high employer retirement contributions, and tuition reimbursement.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Engineer Supplier Development Quality to work in their Heart Failure Division in Pleasanton, CA. The role involves supplier evaluation, material qualification, and maintaining quality engineering methodologies to meet regulatory requirements.

Salary

Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • FDA GMP ISO 13485 regulatory knowledge
  • Supplier selection and evaluation experience
  • Root cause analysis for non-conforming materials
  • Statistical analysis and Gage R&R studies
  • Cross-functional project leadership

Nice-to-have

  • Six Sigma and Lean Manufacturing experience
  • ASQ CQE certification
  • Supervisory or mentoring experience
  • Advanced degree in Engineering
  • International travel capability

Key Requirements

  • Bachelor's Degree in Engineering or Technical Field
  • Minimum 5 years of related experience
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

Work Rights

Not specified

Tailored Resume

Cover Letter