QA Manager – Medical Device Testing

New York, New York
Infostretch Corporation

Infostretch are seeking a Medical Device Software QA/Testing Manager with a minimum of 8+ years for NYC location.

Please note that to start the role it will be remote for 3 – 6 months but once this Covid19 is behind us – it will be onsite role.

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.

– provided by Dice