Quality Engineer

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

• The anticipated salary range for this position is .$60,200.00 - $111,800.00 USD Annual. The actual compensation offered may vary based on job related factors such as experience, skills, education and location

Position Summary

Quality Engineer I will establish, support, and continuously improve the quality system for one or more facilities involved in the distribution, repackaging, and relabeling of medical devices.  Serves as key quality contact for assigned areas of oversight.  Drives reduction of
defects and problem resolution utilizing a variety of investigative and analytical tools

Responsibilities

Initiates and administers programs such as quality metrics, management reviews,cost of quality, training, post-marketing surveillance, risk management, change management and authoring and managing Standard Operating Procedures (SOPs) andWork Instructions (WIs).
• Works with operations to define quality objectives for key performance indicators(KPIs).  Implements associated measurement systems and monitors relevant trends,providing analysis, and interpretation of KPIs for data driven decision making asapplicable.
• Provides oversight of associated quality management system activities to ensure that CAPAs are opened as needed and are resolved in a timely and effective manner;
supports root cause analysis through training and hands-on assistance.
• Conducts validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols as applicable.
• Manages and improves related Quality Program activities (i.e. Master Validation Plan) by designing protocols that involve proper sampling techniques, design of experiments, testing, and statistical rationale as applicable.

Education & Experience

Bachelor’s degree (B.S.) in Engineering or Science required.
• Three (3) or more years of quality engineering experience in a manufacturing
environment required.
• American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification preferred.
• Or any combination of education and experience to meet the above requirements.
 

Knowledge Skills and Abilities

Clear understanding of quality engineering/quality control principles; working
knowledge of statistics, Minitab and/or other statistical software experience. 
• Experience in a medical device manufacturing environment preferred.
• Medical Device experience, knowledge of 21 CFR Part 820, (ISO 13485 a plus)
preferred.
• Working knowledge of Title 21 Code of Federal Regulations and other Federal and
State regulations applicable to O&M's private brand products.
• Working knowledge of electronic quality/regulatory software a plus.
• Ability to work independently and as part of a team.
• Good verbal and written communication skills; strong interpersonal skills.
• Strong analytical capabilities with demonstrated skill in evaluating reports,
identifying issues, noting trends, and reporting to these observations to management.
• Must be able to define problems, collect data, establish facts and draw conclusions.
• Ability to analyze and conclude.
• Ability to motivate and direct the work of teammates in multiple facilities in
designated areas of responsibility.
• Effective project manager with ability to handle multiple tasks simultaneously
prioritizing appropriately.
 
ADDITIONAL
REQUIREMENTS • Ability to travel on a limited basis, up to 50%.
PREVIOUS JOB PROFILE 
 

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.