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 Product Quality Analyst III position is a leading subject matter expert for the complaint handling program ensuring regulatory and compliance obligations are understood and implemented. This role serves as a liaison between manufacturing facilities, the medical director, and customers regarding product quality complaints and adverse event handling. This role is also the point of contact for resolving complaint issues and providing regional complaint handling guidance and assistance.
Job Position Scope:
The incumbent reports to Quality Systems Compliance Manager.
Essential Job Functions:
- The Product Quality Analyst III is responsible for ensuring the process for receiving, filing, documenting and routing, via the electronic Complaint System, all complaints alleging product deficiencies for products manufactured and/or distributed by Owens and Minor is robust and compliant.
- Utilize clinical and technical product knowledge and experience to make initial potential reportability decisions using the Preliminary Reportability Evaluation questions and information provided within the complaint record.
- Serves as a primary point of contact for customers experiencing product quality issues and concerns.
- Responsible for conducting due diligence attempts in order to obtain adequate incident information to make appropriate vigilance reporting decisions and for manufacturing sites to conduct appropriate investigations.
- Responsible for creating summaries of investigation conclusions and for providing timely complaint response to customers.
- Supports new product launches and changes by ensuring complaint management system is appropriate and provides a suitable means to support customer complaint reporting.
- Facilitates process and enterprise management tool improvements related to complaint handling and the associated module.
- Supports external inspections and audits, such as Notified Body Audits, and the Federal Food and Drug Agency (FDA).
- Facilitates complaint training for other regional complaint intake teammates and Sales/Marketing.
- Prepares for and participates in QA review forums such as the Complaint Review Board, Gemba and Management Review.
Supplemental Job Functions:
- Demonstrate leadership and initiative to cause positive change that will result in overall improved effectiveness, quality, and productivity within the business.
- Actively seek and positively respond to performance and personal development feedback.
- Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
Qualifications:
- Proficient in Microsoft Office applications.
- Demonstrated success in fast paced environment.
- Strong oral and written communication, analytical skills, and organizational skills.
- Technical writing skills.
Knowledge Skills & Abilities:
- Acute Care, Operating Room, or other clinical experience preferred.
- Experience with complaint handling systems.
- A fundamental working knowledge of ISO, FDA, cGMP regulations.
- Certified Quality Auditor.
- Leadership or supervisor experience.
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.