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Quality Assurance and Regulatory Affairs Engineer

Company: Mercury Medical
Location: Clearwater
Posted on: February 10, 2020

Job Description:

Mercury Medical is a Specialty Healthcare Organization dedicated to bringing innovative medical devices to the market. Our mission is to provide customers with the highest quality airway products while providing value for creating better patient outcomes in EMS and hospital settings -- Mercury Medical is looking to add a Quality Assurance Engineer with a focus on Regulatory Affairs.--This position will require a dynamic well-rounded individual who is detail oriented and well organized.--A sound understanding of Quality Management Systems will aid in success. -- Primary Responsibilities: CE Technical File Support and Maintenance Risk Management File Support and Maintenance Regulatory Submissions -- Support Responsibilities: Complaint Handling Corrective/Preventative Actions Calibration System Maintenance Supplier Evaluations/Monitoring Product Testing Product and Process Validations Non-conformance Reporting Recalls Quality Trending Manufacturing Floor Support Internal and External Audit Support -- Education/Qualifications: Bachelor's degree preferably in a regulatory, or scientific/technical discipline Must possess excellent verbal and written skills Attention to detail required Ability to interact and support multiple teams Minimum of 3 years in an ISO 13485, MDSAP and EU MDD environment -- Travel: Periodic international travel may be required -- Job Type: Full-time

Keywords: Mercury Medical, Clearwater , Quality Assurance and Regulatory Affairs Engineer, Engineering , Clearwater, Florida

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