Sr. Capa Quality Engineer

Abbott

Alameda, CA, US
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Onsite
Lead capa projects through entire life cycle
Mentor lower-level quality engineers
Ensure fda 21 cfr part 820 compliance
This position is responsible for driving CAPA projects through their entire life cycle while mentoring a team of quality engineers

Job Summary

  • This position is responsible for driving CAPA projects through their entire life cycle while mentoring a team of quality engineers.
  • The role requires accountability for the leadership and oversight of the CAPA system and associated deliverables within Abbott Diabetes Care.
  • Employees qualify for free medical coverage, an excellent retirement savings plan with high employer contribution, and tuition reimbursement benefits.

Matching Summary

This position is responsible for driving CAPA projects through their entire life cycle while mentoring a team of quality engineers.

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

  • Lead CAPA projects through entire life cycle
  • Mentor lower-level Quality Engineers
  • Ensure FDA 21 CFR Part 820 compliance
  • Provide subject matter expertise during audits
  • Drive continuous improvement initiatives

Nice-to-have

  • Prior medical device experience preferred
  • Solid communication and interpersonal skills
  • Ability to work in matrixed environment
  • Strong project management leadership skills
  • Advanced statistical data analysis skills

Key Requirements

  • B.S. in Engineering or related discipline
  • Minimum 6 years in Quality field
  • Detailed knowledge of ISO 13485: 2016
  • Masters degree preferred
  • Ability to travel approximately 20%

Work Rights

Not specified

Tailored Resume

Cover Letter