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Quality Engineer
Ref No.: 18-49716
Location: Salt Lake City, Utah
Position Type:Full Time/Contract
Experience Level: 9 Years
Start Date: 07/16/2018
 
Technical/Functional Skills
Must have skills*
Excellent Knowledge of Medical Device Design Control Requirements, Update Design History File and Risk Management File, FMEA, Statistical Methods, Good knowledge and understanding of EU MDR Regulations, US FDA regulations, ISO-13485 requirements, Must demonstrate leadership skills in team setting, Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends
 
Good to have skills*
Experience working with Venous Catheters, Ports desired, Minimum of 8 years of experience within the medical device industry with a Bachelor's degree or advanced degree (Master's or PhD) plus 5 years of engineering experience within the medical device or equivalent industry.
Experience Required 8+ years with at least 5 years in Medical Device Industry
Roles & Responsibilities Gap Assessment and remediation strategy for EU MDR Compliance, Implementation of changes, Identify all applicable documentation, Identify missing documentation, Baseline product Testing, Creating and assessment of gaps, All gaps are defined, DIR and RM updates, author/ review/ approve V&V Protocols, Reports, Process Validation and Component Qualification work, Updates to reflect remediation activities, contribute in compilation of Design Dossiers, 510(k), PMA etc.
Generic Managerial Skills The Senior Quality Engineer ensures project is as per schedule and provides guidance to team members, should be a self-starter and able to function with minimal guidance.
Education B.S. or B.A. degree required.  MS preferred