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Sr. Software Quality Engineer

Company: ATR International
Location: Redwood City
Posted on: June 4, 2021

Job Description:

We are seeking a Sr. Software Quality Engineer for a very important client.The Sr. Software Quality Engineer is responsible for sustaining Quality Assurance activities related to currently released software and firmware. This is a hands-on role where the Sr. Software Quality Engineer will apply diversified knowledge of software engineering, software verification, recognized software development standards and quality principles and practices for implantable medical devices and accessories. This position will report to Manager, Quality Assurance.Follow procedures to guide software and systems development and ensure best engineering practice compliance with relevant regulatory requirementsLead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:Risk ManagementCyber security Risk assessmentSystems ValidationQuality InvestigationsTraceabilitySoftware DesignParticipate in cybersecurity, post market vulnerability assessments and other risk management processesSupport internal and external regulatory audits, and other quality assurance functions.Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.Demonstrate understanding of software best practicesWork with departments to discuss system gaps, fixes, design solutions and risks.Perform other duties as required Requirement: The ideal candidate will possess the following qualifications:Role RequirementsBachelor's degree in a technical or science majorEquivalent work experience may be substituted for education requirementSkills and Knowledge5+ years of Quality /Regulatory experience in a medical device or other regulated industry3 years? experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.Experience working with Cloud based infrastructure and systems that process, store, and distribute large sets of data continuously.FDA Software guidance of Verification & ValidationActive Implantable Medical Device Directives (90/385/EEC)Understand and working knowledge of IEC 62304, EN ISO 14971, AAMI TIR 57, AAMI TIR 97, IEC 60601-4-5IEC 62443-3-1, IEC 30111, FDA Software Guidance or similar standards,Highly developed written and oral communication skills and be able to work in a team environmentMust have good problem solving skills and be able to work independentlyWorking knowledge of Corrective Action & Prevention methodology for nonconformity mitigationMust be organized, detail-oriented and adaptable according to evolving situations at hand.ASQ Certified Software Quality Engineer (CSQE) preferred.

Keywords: ATR International, Redwood City , Sr. Software Quality Engineer, Other , Redwood City, California

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