Software Quality Assurance Engineer

Overview:

This role is responsible for establishing, executing and maintaining software quality assurance standards and measures across the organization. This position will apply proven analytical, problem-solving and quality assurance/testing skills to maximize the benefit of business investments in software initiatives and ensure products are designed, developed, tested and manufactured in accordance with applicable regulatory requirements, customer/patient expectations and best practice industry standards.

Essential Responsibilities:

  • Participate in all phases of the project life cycle (e.g., requirements development/review/approval, test planning, test execution, and test reporting and assessment

  • Plan, monitor and manage all SQA and testing activities throughout the project lifecycle

  • Prepare test plans through characterization of testing evolutions – system, integration, functional, performance, regression testing and user acceptance

  • Manage test schedules and track and communicate testing progress to project stakeholders

  • Implement and lead routine reviews with project stakeholders to ensure all deliverables meet expectations and timeline commitments

  • Collaborate with R&D Software and IT to analyze complex challenges and recommend solutions to stakeholders and project team

  • Partner with R&D Software and IT to develop standards and best practices to improve efficiency and over-all quality of work delivered by the project team

  • Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained

  • Serve as Subject Matter Expert for regulatory inspections related to Software Quality Assurance

Education/Experience:

REQUIRED EDUCATION:

  • BS Degree in Mechanical, Electrical or Biomedical Engineering or equivalent 4 year degree

REQUIRED QUALIFICATIONS:

  • 5+ years software quality (SQA) experience

  • 3+ years Class II or Class III medical device experience

  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices

  • Expertise related to software validation requirements in the medical device industry or other highly regulated industry

  • Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules

  • Able to constructively collaborate with cross-functional teams

  • Software testing experience related to medical device industry

  • Working knowledge of quality assurance methodologies

  • Ability to follow instructions, work independently, or function in a team as needed

  • Knowledge of commonly used concepts, practices and procedures for full product development life-cycle

DESIRED QUALIFICATIONS:

  •  Experience with electro-mechanical devices

  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager)

  • Demonstrated ability to act as Subject Matter Expert related to Software Quality Assurance

  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role

 

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