Product Quality Assurance Analyst Ii

Abbott

Alameda, California, United States
Base: $100,000.00 – $200,000.00; bonus/equity: not...
Product manufacturing quality regulatory safety issues
Customer complaints exception reports technical investigations
Cross functional meetings product controls risk evaluations
The primary function of a Product Quality Assurance Analyst II is to serve as a facilitator to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by Abbott Diabetes Care (ADC)

Job Summary

  • The primary function of a Product Quality Assurance Analyst II is to serve as a facilitator to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by Abbott Diabetes Care (ADC).
  • Abbott offers access to career development with an international company, an excellent retirement savings plan with a high employer contribution, and tuition reimbursement programs.
  • Abbott is recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

Matching Summary

The primary function of a Product Quality Assurance Analyst II is to serve as a facilitator to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by Abbott Diabetes Care (ADC).

Salary

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

Skills & Requirements

Must-have

  • product manufacturing quality regulatory safety issues
  • customer complaints exception reports technical investigations
  • cross functional meetings product controls risk evaluations
  • stop shipments quality holds dispositions
  • design reviews technical inputs historical information
  • process improvements procedures work instructions
  • team metrics data for Post-Market Surveillance reviews

Nice-to-have

  • career development international company
  • health investment plan medical plan
  • retirement savings plan employer contribution
  • tuition reimbursement student debt program
  • recognized great place to work
  • diversity working mothers female executives scientists

Key Requirements

  • Bachelors Degree with a minimum of 6 yrs relevant work experience
  • Minimum 3 yrs at a Senior Specialist level
  • Prior experience in medical device industry
  • Prior experience in quality systems
  • Strong working knowledge of FDA Code of Federal Regulations
  • cGMP ISO14971 complaint handling systems
  • Proven track record managing projects

Work Rights

Not specified

Tailored Resume

Cover Letter