Specialist Quality Assurance

Abbott

Alameda, California, United States
Base: $81,500.00 – $141,300.00; bonus/equity: not ...
Onsite
Capa ownership from initiation to closure
Authoring and redlining sops and wis
Knowledge of 21 cfr 803/820/806 regulations
Abbott is seeking a Specialist Quality Assurance professional to join their Complaint Handling Group in Alameda, California. The role focuses on managing CAPA processes and ensuring compliance with various regulations while fostering continuous improvement in complaint handling

Job Summary

  • The Quality Assurance Specialist will own and drive CAPA processes while authoring and maintaining quality procedures for Abbott Diabetes Care.
  • This onsite role requires ensuring the complaint handling process remains inspection-ready and aligned with FDA QSR, ISO 13485, and EU MDR requirements.
  • Employees benefit from career development opportunities, free medical coverage options, and a high employer contribution retirement savings plan.

Matching Summary

Match Score: 85

Abbott is seeking a Specialist Quality Assurance professional to join their Complaint Handling Group in Alameda, California. The role focuses on managing CAPA processes and ensuring compliance with various regulations while fostering continuous improvement in complaint handling.

Salary

Base: $81,500.00 – $141,300.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • CAPA ownership from initiation to closure
  • Authoring and redlining SOPs and WIs
  • Knowledge of 21 CFR 803/820/806 regulations
  • Experience with ISO 13485 and ISO 14971 standards
  • Proficiency in complaint management systems like TrackWise
  • FDA QSR and EU MDR compliance expertise

Nice-to-have

  • Data trending and root cause analysis skills
  • DMAIC, 5 Whys, or Fishbone methodology experience
  • Audit support as a Subject Matter Expert
  • Strong cross-functional collaboration abilities
  • Ability to work independently in fast-paced environments

Key Requirements

  • Associate's degree required
  • 1 year of relevant experience required
  • 3+ years preferred in medical device complaint handling
  • Working knowledge of global regulatory frameworks

Work Rights

Not specified

Tailored Resume

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