Senior Quality Assurance Engineer

Abbott

Alameda, California, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Fully remote
Bachelor's degree in engineering or life sciences
Minimum 5 years supplier quality experience
Experience with iso 13485 and fda qsr regulations
Abbott is seeking a Senior Quality Assurance Engineer to lead supplier quality assurance activities, ensuring compliance with regulatory requirements in the medical device and consumer sectors. The role emphasizes collaboration across various departments and requires expertise in supplier audits, risk management, and quality metrics

Job Summary

  • The Senior Supplier Quality Assurance role is responsible for developing and executing supplier quality strategy while ensuring compliance with global regulatory requirements.
  • Employees enjoy access to career development opportunities, free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
  • This position serves as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Quality Assurance Engineer to lead supplier quality assurance activities, ensuring compliance with regulatory requirements in the medical device and consumer sectors. The role emphasizes collaboration across various departments and requires expertise in supplier audits, risk management, and quality metrics.

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

  • Bachelor's degree in engineering or Life Sciences
  • Minimum 5 years Supplier Quality experience
  • Experience with ISO 13485 and FDA QSR regulations
  • Proficiency in root cause analysis and CAPA management
  • Demonstrated experience conducting supplier audits

Nice-to-have

  • Advanced degree or professional certifications like Six Sigma
  • Direct medical device manufacturing experience
  • Experience with PPAP, FAI, and PFMEA methodologies
  • Strong cross-functional leadership and communication skills
  • Ability to travel up to 10% annually

Key Requirements

  • Bachelor's degree required
  • Minimum 5 years of regulated environment experience
  • Knowledge of MDR/IVDR and ISO 14971
  • Experience leading supplier audits
  • Ability to manage multiple priorities in fast-paced environments

Work Rights

Not specified

Tailored Resume

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