Product Quality Assurance Analyst Ii

Abbott

Alameda, California, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
Medical device industry experience
Fda code of federal regulations knowledge
Cgmp and iso14971 compliance
The role serves as a facilitator to identify and assess the impact of worldwide product manufacturing and quality issues within Abbott Diabetes Care

Job Summary

  • The role serves as a facilitator to identify and assess the impact of worldwide product manufacturing and quality issues within Abbott Diabetes Care.
  • Candidates will draft, review, and issue stop shipments, quality holds, and dispositions while initiating risk evaluation processes.
  • Abbott offers comprehensive benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement.

Matching Summary

Match Score: 85

The role serves as a facilitator to identify and assess the impact of worldwide product manufacturing and quality issues within Abbott Diabetes Care.

Salary

Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Medical device industry experience
  • FDA Code of Federal Regulations knowledge
  • cGMP and ISO14971 compliance
  • Risk management and evaluation
  • Technical writing skills

Nice-to-have

  • Cross-functional meeting facilitation
  • Project management from initiation to completion
  • Experience with Post-Market Surveillance
  • Leadership direction for junior staff

Key Requirements

  • Bachelor's Degree with minimum 6 years relevant work experience
  • Minimum 3 years at Senior Specialist level
  • Prior experience in medical device industry or quality systems
  • Strong working knowledge of FDA regulations and complaint handling systems

Work Rights

Not specified

Tailored Resume

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