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QA Manager Medical Device Testing

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Company :
Opallios Inc

Location :
New York City, New York

Expiry Date :
Sun, 28 Mar 2021 23:59:59 GMT

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Description :
Job Title: QA Manager – Medical Device Testing Job Location: NYC, NY Job Description: Essential Responsibilities include (but are not limited to): Establish, monitor, and execute software quality assurance policy (QAP) and design assurance/control process to contribute to building high quality products. Serve as a subject matter expert for all design control operations in a regulated environment. Job description * Author, maintain, explain, and manage application products QAP and associated design assurance/control deliverables through the SDLC process. * Review, evaluate, and document quality assurance/testing (QA) processes and contributors. * Achieve/maintain product compliance with ISO, IEC, and FDA quality system regulations. * Proactively monitor changing regulatory and compliance requirements to identify potential compliance gaps and translate into new process and product requirements. * Manage software quality engineering functions, resources, and processes/tools across multiple sites to ensure quality milestones are met within defined budgets and schedule. * Create per-release QA plans that match the needs of various mobile application products and releases along with and final reports for Design Control signoff. * Review, evaluate, document dedicated/shared/contributed hardware testing environments. * Ensure test coverage across a broad range of environments, testing all elements of the release process. * Support regulatory affairs management in interactions with FDA and Notified Bodies during inspections and certifications. * Prepares documentation to support regulatory filings including 510k submissions, device master files, technical files, and post market surveillance. * Evaluate and provide for audits, correctives actions and compliance verification of internal and external vendor quality design control systems and functions. Preferred skills and Experience: * BS degree or higher in Information Systems, Computer Science, Engineering, Business, or related field. * 5+ years of experience applying organized quality assurance principles. * 5+ years of experience in performing program assessments, inspecting work products across the full lifecycle, and developing QA processes and metrics * 4+ years of experience in testing iOS and Android mobile applications, Bluetooth, near field communication, and web API connectivity. * 3+ years of experience in testing system or product classified as software medical devices (ISO 13485, IEC 62304) and design control technologies. * 3+ years of experience testing systems handling PHI (HIPAA) or payment card information (PCI DSS). * 2+ years of experience in leading quality assurance teams on distributed applications. * Experienced in working with offshore and onshore vendors. * Experienced in managing challenges such as cross-team dependencies, changing schedules, and product evolution. * Excellent verbal and written communication skills that are appropriate at all levels in an Organization. * Strong analytical and problem-solving skills. * Demonstrates high levels of personal responsibility and customer commitment. * Ability to work independently and in a team. * Willing to work on testing all landscape components. Best Regards, Afreen fatima|| Senior Recruiter 3375 Scott Blvd || Ste 406 || Santa Clara || CA 95054 (O) +1 ||