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 day401(k), eligibility after 30 days of employmentEmployee stock purchase planTuition reimbursementDevelopment opportunities to grow your career with a global companyJob Summary
Establishes, supports, and continuously improves 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.
Core 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) and Work 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 as applicable.
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.
Qualifying Experience
Associates or Bachelor’s degree (B.S.) in Engineering or Science preferred but not required
Three (3) or more of quality engineering experience in a manufacturing environment
American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification preferred
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
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 motivate and direct the work of teammates in multiple facilities in designated areas of responsibility
Ability to travel on a limited basis up to 20 - 40%
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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.