Quality Engineer

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Arden, NC, USA
In-Office
Healthtech
The Role

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.

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The Company
HQ: Mechanicsville, VA
12,252 Employees
Year Founded: 1882

What We Do

Owens & Minor, Inc. (NYSE: OMI) is a Fortune 500 global healthcare solutions company providing essential products and services that support care from the hospital to the home. For over 100 years, Owens & Minor and its affiliated brands, Apria® , Byram®, and HALYARD*, have helped to make each day better for the patients, providers, and communities we serve. Powered by more than 20,000 teammates worldwide, Owens & Minor delivers comfort and confidence behind the scenes so healthcare stays at the forefront. Owens & Minor exists because every day, everywhere, Life Takes Care™.

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