Manager, Product Quality Engineering

Abbott

Alameda, CA, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
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Fda/iso regulated environment experience
Capa system investigation methodology
Post-market surveillance process establishment
** Abbott is seeking a Manager for Product Quality Engineering in Alameda, CA, to oversee product quality investigations and ensure post-market surveillance for new diabetes care technologies. The ideal candidate will have substantial experience in quality assurance within FDA/ISO regulated environments, strong problem-solving skills, and a proven ability to lead teams. **

Job Summary

  • This role is responsible for initiating and owning investigations associated with trends and emerging issues in the CAPA system within the Diabetes Care division.
  • The position requires establishing processes to ensure new products are capable for post-market surveillance at the time of launch while overseeing a team of quality engineers.
  • Abbott offers comprehensive benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement programs.

Matching Summary

Match Score: 75

** Abbott is seeking a Manager for Product Quality Engineering in Alameda, CA, to oversee product quality investigations and ensure post-market surveillance for new diabetes care technologies. The ideal candidate will have substantial experience in quality assurance within FDA/ISO regulated environments, strong problem-solving skills, and a proven ability to lead teams. **

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • FDA/ISO regulated environment experience
  • CAPA system investigation methodology
  • Post-market surveillance process establishment
  • Root cause analysis and troubleshooting
  • Team leadership and development skills

Nice-to-have

  • Healthcare industry discipline background
  • Strong critical-thinking and problem-solving
  • Cross-functional collaboration with R&D
  • Experience in new product development oversight

Key Requirements

  • Bachelor's Degree required
  • Minimum 6 years overall experience
  • Minimum 4 years in FDA/ISO regulated environment
  • Substantial demonstrated initiative and problem-solving skills
  • Experience leading and managing people

Work Rights

Not specified

Tailored Resume

Cover Letter