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