Quality Engineer Ii (onsite)

BD

Sumter, SC, United States
Fully remote
Iso and fda guidelines
Strategic quality plans
Regulatory compliant operating procedures
The Quality Engineer II performs a variety of compliance related duties associated with the medical devices manufactured at the BD site in Sumter, SC

Job Summary

  • The Quality Engineer II performs a variety of compliance related duties associated with the medical devices manufactured at the BD site in Sumter, SC.
  • This position is integral to the design and maintenance of quality systems to meet ISO and FDA guidelines, while working with a variety of local, US based and international resources at all levels of the company.
  • BD is one of the largest global medical technology companies in the world, advancing the world of health™ by looking at the impossible and finding transformative solutions.

Matching Summary

The Quality Engineer II performs a variety of compliance related duties associated with the medical devices manufactured at the BD site in Sumter, SC.

Skills & Requirements

Must-have

  • ISO and FDA guidelines
  • strategic quality plans
  • regulatory compliant operating procedures
  • manufacturing processes and products
  • pFMEAs, risk mitigation, site validations
  • vendor quality evaluations
  • Six Sigma, 8D, 5-Why

Nice-to-have

  • human element across global teams
  • learn, grow and become your best self
  • makers of possible
  • reinvent the future of health
  • culture of excellence

Key Requirements

  • 3 years work experience in Quality Assurance/Manufacturing
  • Validations, IQ, OQ, PQ and DOE tools
  • Statistical/investigative tools
  • Effective written and verbal skills
  • ASQ CQE or Six Sigma Green Belt (preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter