Quality Engineer

Owens & Minor•Asheville, NC

13d

About The Position

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement Job Summary The Quality Engineer uses their personal experience and judgment applying learned engineering methodologies and other analytics to initiate, implement, and manage the master validation plan within the facility. The Engineer will have responsibility for improving operational effectiveness through the refinement of existing procedures or business processes to optimize validations. The Quality Engineer will be a key resource for new product and machine validations providing subject matter expertise.

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.

Nice To Haves

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