Senior Quality Engineer

Reposted 4 Days Ago
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Toano, VA
In-Office
Senior level
Healthtech
The Role
The Senior Quality Engineer is responsible for managing the Master Validation Plan, coordinating validation tests, and improving processes in the Quality Management System.
Summary Generated by Built In

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 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 30 days of employment
  • Employee stock purchase plan
  • Tuition reimbursement
  • Development opportunities to grow your career with a global company

 At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 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 30 days of employment
•    Employee stock purchase plan
•    Tuition reimbursement
•    Development opportunities to grow your career with a global company
The Senior Quality Engineer uses their advanced professional experience and judgment applying learned engineering methodologies and other analytics to initiate, implement, improve and manage the Master Validation plan and key process within Our Quality Management System.  The Senior Quality Engineer have the responsibility to coordinate the Quality Engineering group on improvement of operational effectiveness, new product and machine validations providing subject matter expertise.

Core Responsibilities
•    Creates, manages, improves and Coordinate the Master Validation Plan;  designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide statistical rationale.
•    Conducts and Coordinate validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards.
•    Conducts and Coordinate sterilization validations in accordance with internal protocols and external standards.  Supports activities related to the master sterilization plan and Product Adoption process.
•    Develops, manages and Coordinate 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 and Coordinate analysis and interpretation of report data including the use of systems. 
•    Creates, Manages, Improves and Coordinate key processes within the Quality Management System such as CAPA,  PM records, Calibration, environmental controls and Change Control; design structures that maintain compliance to internal protocols and external standards and support and coordinates Quality Improvements projects for complaint & Nonconformance reductions.

Qualifying Experience
•    Bachelor’s degree (B.S.) in Engineering or other technical degree from a four-year college or university is required. 
•    Eight plus 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.

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.

Top Skills

Excel
Minitab
SAP
Word
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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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