62 applicantsPosted by Agency

Company

Original Job Post

Kforce Inc · 2 days ago

Senior FDA Design Quality Engineer

San Diego, CA

Full-time

Remote

Mid, Senior Level

5+ years exp

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Responsibilities

The Medical Device Software Quality Engineer will work with software teams, RA and NPD teams to ensure that the software projects are meeting regulations and quality standards

Take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development

Handle the Design Control process from beginning to end - will handle all 5 steps

Creates and reviews various software lifecycle project deliverables based on procedural requirements

Performs risk analysis and is responsible for risk management activities determines, evaluates, and documents software risks from product design to post-launch

Provides traceability analysis and traceability reports to ensure project requirements have been met

Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies

Work with software teams, RA, NPD teams as well as other teams

As a Medical Device Software Quality Engineer, you will review and approve CO's as well as provides quality input to support closure (QMS updates, Procedural changes, etc.)

Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable

Please note that this role will not be responsible for any software development or software testing; This is an FDA Medical Design Quality Engineering position

Qualification

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Medical Device QualityRisk AnalysisRisk ManagementFDA Design ControlSoftware Development LifecycleProduct LaunchProduct PlanningProblem-SolvingTeamworkMobile App Technologies

Required

BS degree in Engineering, Biotechnology, or Computer Sciences or related field or equivalent combination of education and years of applicable experience

At least 5-8+ years of experience acting as a Medical Device Quality Engineer on software projects and guiding cross-functional teams towards compliance in an FDA-regulated industry

Strong working experience in Risk Analysis and Risk Management processes

Experience with the FDA Design Control process is required. Must know at least 4 to 5 steps of the design control process

Working knowledge of federal and other regulations including QSRs, ISO 14971, IEC 62304 are required

Skilled at promoting team cooperation and a commitment to team success

A strong understanding of the Software Development Lifecycle (SDLC)

Experience with product launch and product planning is important

Preferred

Knowledge of mobile app technologies is a plus but not required

Benefits

Medical/dental/vision insurance

HSA

FSA

401(k)

Life insurance

Disability insurance

ADD insurance

Paid time off

Company

Kforce Inc

Glassdoor

3.8

Kforce is a solutions firm specializing in technology and other professional staffing services.

Founded in 1962

Tampa, Florida, USA

1,001-5,000 employees

http://www.kforce.com

H1B Sponsorship

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