Quality Engineer at Owens & Minor

Arden, North Carolina, United States

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Bachelor’s degree (B.S.) in Engineering or other technical degree from a four-year college or university is required
Four to six years of experience in the Quality field is required
Three to five years of experience in a manufacturing environment is preferred
Green/Black Belt Certification or Lean Manufacturing training is preferred
Medical Device experience is preferred
Knowledge of ISO 13485 and sterilization procedures is preferred
Experience with Minitab is preferred

Creates, manages, and improves the Master Validation Plan; designs protocols utilizing proper sampling techniques, strong design of experiments, and tests, providing statistical rationale
Conducts validation or qualification tests on new or existing equipment, processes, or software in accordance with internal protocols or external standards
Conducts sterilization validations in accordance with internal protocols and external standards
Supports activities related to the master sterilization plan
Develops and manages aging studies for packaging, coordinating testing, analyzing data, and documenting results
Leverages various software programs such as Word, Excel, SAP, Minitab, and other necessary programs or project tools to manage and analyze data and complete work
Provides analysis and interpretation of report data, utilizing systems
Leads Risk Analysis
Responsible for KPI improvement on the production floor
SME for Change Control
Performs additional duties as directed