Manager, Quality Assurance

Abbott

Atlanta, Georgia, United States
Base: $99,300.00 – $198,700.00; bonus/equity: not ...
Quality management system compliance
Audit readiness initiatives
Capa system oversight
The incumbent defines and develops strategy for external and internal audits to ensure that the site is compliant and audit ready at all times

Job Summary

  • The incumbent defines and develops strategy for external and internal audits to ensure that the site is compliant and audit ready at all times.
  • Responsible for oversight and administration of site’s CAPA system and driving effective resolutions to identified issues.
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life.

Matching Summary

The incumbent defines and develops strategy for external and internal audits to ensure that the site is compliant and audit ready at all times.

Salary

Base: $99,300.00 – $198,700.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Quality Management System compliance
  • audit readiness initiatives
  • CAPA system oversight
  • external regulatory requirements
  • cross-functional audit support

Nice-to-have

  • influential leadership
  • proactive compliance gap addressing
  • business climate understanding
  • quality excellence focus

Key Requirements

  • Bachelors Degree in related field
  • Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience
  • Five (5) years in a management capacity
  • Knowledge of MDD, MDSAP, MDR, NMPA and applicable US CFR 803, 806 and 820, ISO 13485 and 14971

Work Rights

Not specified

Tailored Resume

Cover Letter