Quality Engineer
| Company | Owens & Minor |
|---|---|
| Location | Asheville, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- 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 preferred.
- Green/Black Belt Certification or Lean Manufacturing training preferred.
- Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred.
Responsibilities
- Creates, manages and improves the Master Validation Plan; designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide 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 which may include 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 including the use of systems.
- Leads Risk Analysis.
- Responsible for KPI improvement on the production floor.
- SME for Change Control.
- Performs additional duties as directed.
Preferred Qualifications
- Three to five years of experience in a manufacturing environment preferred.
- Green/Black Belt Certification or Lean Manufacturing training preferred.
- Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred.