Product Quality Assurance Analyst Iii

Abbott

Alameda, California, United States
Base: $112,000.00 – $224,000.00; bonus/equity: not...
Onsite
Medical device industry experience
Fda cgmp and iso14971 knowledge
Risk evaluation facilitation
Abbott is seeking a Product Quality Assurance Analyst III to join their team in Alameda, California. The role involves managing product nonconformances, conducting risk evaluations, and facilitating cross-functional collaborations to ensure compliance with quality standards in the medical device industry

Job Summary

  • The role involves reviewing escalated customer complaints and manufacturing deviations to identify new issues and conduct risk evaluations for Abbott Diabetes Care products.
  • Employees will facilitate cross-functional meetings to recommend product controls and manage the approval of risk evaluations with senior management input.
  • Abbott offers comprehensive benefits including free medical coverage options, a high employer contribution retirement plan, and tuition reimbursement programs.

Matching Summary

Match Score: 90

Abbott is seeking a Product Quality Assurance Analyst III to join their team in Alameda, California. The role involves managing product nonconformances, conducting risk evaluations, and facilitating cross-functional collaborations to ensure compliance with quality standards in the medical device industry.

Salary

Base: $112,000.00 – $224,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Medical device industry experience
  • FDA cGMP and ISO14971 knowledge
  • Risk evaluation facilitation
  • Customer complaint investigation
  • Product nonconformance management

Nice-to-have

  • Cross-functional team leadership
  • Process improvement implementation
  • Executive presentation skills
  • Mentoring junior staff members
  • Audit response support

Key Requirements

  • Bachelor's degree required
  • Minimum 8 years of relevant experience
  • Prior medical device quality systems experience
  • Strong technical writing skills
  • Knowledge of FDA Code of Federal Regulations

Work Rights

Not specified

Tailored Resume

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