Quality Engineer Position Available In Buncombe, North Carolina

Quality Engineer Quality Engineer locations
Arden, NC
time type
Full time
posted on
Posted 14 Days Ago
job requisition id
REQ_25_25586
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.
Main 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
Education and Experience
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.
If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
About Owens & Minor
Owens & Minor (O&M) is a global healthcare company providing innovative products and solutions across the continuum of care. Our integrated technology, products, and services empower healthcare providers and manufacturers as they make a difference in the lives of patients every day. O&M is headquartered in Richmond, Virginia and is comprised of 17,000+ global teammates. We operate within distribution, production, customer service, and sales facilities located across the Asia Pacific region, Europe, Latin America and North America. We are proud to service healthcare industry customers in 90 countries where we do business today.
Life at O&M
When you become an Owens & Minor teammate, you’re joining a diverse, vibrant organization with a focus on excellence and integrity. Guided by our shared values—Integrity, Development, Excellence, Accountability, Listening—O&M teammates strive to deliver superior service across the continuum of healthcare. O&M is committed to creating a growth-oriented culture that values each teammate’s perspective and contributions.