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Senior Quality Engineer
Ref No.: 18-50179
Location: Salt Lake City, Utah
Position Type:Full Time/Contract
Start Date: 07/17/2018
RGS ID 2418905
RGS ID creation date
(dd-mmm-yy)
7-JUL-18
# of requirements 1
Job Title Senior Quality Engineer
Relevant Experience
(in Yrs)
8-10 years
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
Start date (dd-mmm-yy) 1-Sep-18
Duration of assignment (in Months) Long Term
Work Location (State, City and Zip) Salt Lake City, UT
Client Billing Rate $/hr
Rates payable to vendor $/hr
Key words to search in resume Medical Devices, US FDA, EU MDR, EU MDD, 510(k), PMA, Note to File, Regulatory Affairs
Prescreening Questionnaire The job profile requires working with cross functional team to ensure compliance to FDA and other applicable regulations. In this role, Consultant will mainly sustaining existing product lines by supporting review and implementation of Change Control Plans and ensuring compliance to regulations of various agencies. Supports applicable regulations including ISO, local, state, and/or federal requirements. Responsible for understanding product registration and re-registration requirements in various countries and working with local regulatory teams to support product lines