Quality System Specialist Ii

BD

Sumter, SC, USA
Fully remote
Fda and iso compliance
Corrective/preventive actions system management
Internal and external auditing
The Quality System Specialist II is responsible for management of the plant’s corrective/preventive actions, internal audits system, customer complaints and other activities related to FDA and ISO compliance as assigned

Job Summary

  • The Quality System Specialist II is responsible for management of the plant’s corrective/preventive actions, internal audits system, customer complaints and other activities related to FDA and ISO compliance as assigned.
  • Evaluates customer complaints; including the coordination of documentation review, sample testing, and root cause analysis.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

The Quality System Specialist II is responsible for management of the plant’s corrective/preventive actions, internal audits system, customer complaints and other activities related to FDA and ISO compliance as assigned.

Skills & Requirements

Must-have

  • FDA and ISO compliance
  • Corrective/Preventive Actions system management
  • Internal and external auditing
  • Customer complaint evaluation
  • Root cause analysis

Nice-to-have

  • Interpersonal relations and communication
  • Investigative skills
  • Analytical techniques
  • Continuous Improvement solutions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter