Quality System Specialist Ii

BDX

Sumter, SC, United States
Fully remote
Corrective and preventive action management
Internal and supplier auditing
Customer complaint evaluation and root cause analysis
The Quality System Specialist II supports the plant in identification and resolution of quality assurance and regulatory issues to assure compliance with FDA regulations, ISO standards, and company strategies

Job Summary

  • The Quality System Specialist II supports the plant in identification and resolution of quality assurance and regulatory issues to assure compliance with FDA regulations, ISO standards, and company strategies.
  • Responsibilities include evaluating customer complaints, leading complaint investigations, managing corrective/preventive action systems, and performing internal and supplier audits.
  • BD offers a culture where employees are supported to learn, grow, and become their best selves while contributing to advancing global health.

Matching Summary

The Quality System Specialist II supports the plant in identification and resolution of quality assurance and regulatory issues to assure compliance with FDA regulations, ISO standards, and company strategies.

Skills & Requirements

Must-have

  • Corrective and preventive action management
  • Internal and supplier auditing
  • Customer complaint evaluation and root cause analysis
  • FDA and ISO compliance
  • Dimensional inspections
  • Safety compliance on production floor

Nice-to-have

  • Continuous improvement solutions
  • Interpersonal and communication skills
  • Analytical and investigative techniques
  • Team collaboration and leadership
  • Regulated industry experience

Key Requirements

  • BA/BS Degree required
  • Auditing certification preferred
  • Experience in regulated industry preferred
  • FDA and medical device experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter