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