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SDLC FDA Engineer
(Jobs in Cambridge, MA)
 
Requirement id 75060
Job title Engineer
Job location in Cambridge, MA
Skills required Excel, SDLC, Risk Management Experience, FDA
Open Date 05-Nov-2018
Close Date
Job type Contract
Duration 9 Months
Compensation DOE
Status requirement ---
Job interview type Face to Face interview
   Email Recruiter: coolsoft
Job Description Engineer: Excel, SDLC, Risk Management Experience, FDA

Candidate must be our own W2 Employee

Job Description :


Position: Software Device Quality Engineer


Position Description:


High-Level Description: Software Device Quality Engineer

Responsible for the quality oversight of design control and risk management for software as Medical Device.
Manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.
Review and approve plans, protocols and reports generated as part of the software development process.
Determine and enforce quality and safety requirements in accordance with company needs.



Job Description:

Manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.
Review and approve plans, requirement specifications, test protocols and reports generated as part of the software development process.
Represent Device Quality on cross-functional teams in support of SDLC activities.
Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements for medical devices with software
Review and approve risk management documents
Review and approval for quality issues (e.g. deviation) and technical matters (e.g. design changes and verification) with impact to design control and risk management
Experience in computerized system validation within a regulated environment –
Knowledge of IEC 62304, Medical Device Software
Software Life Cycle processes
Knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements


Requirements:

Bachelors or Masters degree in Life Sciences or Software Engineering
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 75060 while calling.
 
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(Engineer: Excel, SDLC, Risk Management Experience, FDA in Cambridge, MA)
     
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