Product Quality Analyst

November 25

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Owens & Minor

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Healthcare Distribution and Logistics • Healthcare • Healthcare Technology • Supply Chain

10,000+

💰 Post-IPO Debt on 2022-03

Description

• 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.

Requirements

• Proficient in Microsoft Office applications. • Demonstrated success in fast paced environment. • Strong oral and written communication, analytical skills, and organizational skills. • Technical writing skills. • 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.

Benefits

• Medical, dental, and vision insurance, available on first working day • 401(k), eligibility after one year of service • Employee stock purchase plan • Tuition reimbursement