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Medical Device Software Test Lead

Company Description:

Infostretch is a pure-play digital engineering services firm focused on helping companies accelerate their digital initiatives from strategy and planning through execution. We leverage deep technical expertise, Agile methodologies and data-driven intelligence to modernize systems of engagement and simplify human/tech interaction. We deliver custom solutions that meet customers’ technology needs wherever they are in their digital lifecycle. Backed by Goldman Sachs and Everstone Capital, Infostretch works with both large enterprises and emerging innovators -- putting digital to work to enable new products and business models, engage with customers in new ways, and create sustainable competitive differentiation.

Infostretch is seeking a Software QA and Testing Manager with a minimum of 8+ years of experience based in our NYC location.

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:

  • 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.

Education Qualification:

B.S in computer science, software engineering, computer engineering, electrical engineering, or related area of study.




Disclaimer:
If you feel that this is a good match for your skillsets, please submit a current word version of your resume along with a cover letter describing your skills, experience and salary expectations. We are an Equal Opportunity Employer (EOE). You can read our job applicant privacy policy here.

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Job Code: IS-NYC2021021201

Category: Engineering

Job Type: Contractor

Location: New York, NY, USA

Open Positions: 1

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