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For your reference, we have included the original job posting below.
Sr. Specialist, Quality Assurance
Job Number:
24230576
Company Name:
Canon USA & Affiliates
Job Location:
Deerfield Beach, FL US
Job Category:
Information Technology
Sr. Specialist, Quality Assurance
Sr. Specialist, Quality Assurance
Job ID: 2010-2971 Location: US-FL-Deerfield Beach
Experience (Years): 5 Company: Virtual Imaging
Category: Product Support - Technical Support
More information about this job:
Overview:
Virtual Imaging, Inc. is a wholly owned subsidiary of Canon U.S.A., Inc., based in Deerfield Beach, FL. We specialize in the sale, service and maintenance of new and remanufactured diagnostic imaging equipment. Our remanufacturing process utilizes the highest standards and techniques that rival factory new systems in terms of performance, reliability and aesthetics.
We strive to be recognized as the most progressive company in the industry of diagnostic imaging. We offer cost effective solutions, asset management and excellent customer relations in servicing and maintaining new and remanufactured equipment for our clients within numerous geographic areas and market segments.
The Sr. Specialist Quality Assurance for Virtual Imaging establishes and maintains procedures and techniques for quality systems standards to ensure quality levels are maintained for FDA Quality System Regulation (QSR): responsible for complaint handling, CAPA (Corrective Actions and Preventive Actions) and MDR (Medical Device Reporting) to the FDA. In addition they will conduct quality audits and conduct Quality Management Review meetings. The Sr. Specialist QA is also responsible for labeling approvals and document control and oversees FDA Pre-market Notification (PMN) for the products developed by the division.
Responsibilities:
The successful candidate will: * Work with senior management to develop regulatory strategies for FDA approvals. * Direct the division’s FDA regulatory activities and initiatives; assure the quality of records and products along with timely submissions, reports and filings to meet FDA’s regulatory requirements. * Provide regulatory guidance to the division’s product development teams. * Be responsible for regulatory submissions of FDA pre-market notification and 510(k). * Be responsible for regulatory reports of MDR (Medical Device Reporting) and Baseline Reporting to the FDA. * Monitor and audit GMP (Good Manufacturing Practice) and cGMP (current GMP) policy and procedures. The Sr. Specialist, Quality Assurance will also maintain correspondence and other records of all interactions with the FDA. Additionally, they will coordinate and direct strategy and conduct all meetings with the FDA.
Qualifications:
Qualified applicants will demonstrate superior verbal and written communication skills and negotiating skills, and the ability to ensure that the company adheres to the FDA quality and regulatory guidelines. In addition successful candidates will possess a Bachelor’s Degree or equivalent experience, preferably in science/health field. Five to seven years of Quality Assurance experience in a medical device, biotechnology, or other FDA-regulated industry is required.
AA/EOE
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