Senior Software Quality Engineer

Team Horizon is seeking a Senior Software Quality Engineer for a global medical technology company.

Why you should apply:

• Learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. 

What you will be doing:

• Develop, enhance and maintain strategies and plans to improve the overall quality of software, including test coverage and system performance.


• Provides strategic and tactical support of the Quality Engineering Function, based on an understanding of 21 CFR Part 820 and ISO Requirements.


• Owns and facilitates the Design Review and Functional Review Process for software products.


• Collaborates with Manufacturing and R&D to support software products, driving design improvements and monitoring measurable enhancements. Routinely interacts with multifunctional groups.


• Ensures  PI Systems divisional, departmental policies, procedures, practices, and facilities are in compliance with all applicable regulatory guidelines.


• Represent the Quality Function for New Product Development Core Teams and/or Technology Transfer Core Team


• Plays a key role as a core team member in software development projects, handling various tasks such as requirements, SW development planning, risk management, V&V, and other work.


• Remediates software-related audit findings and CAPAs.

What you need to apply:

• Bachelor’s degree in Electrical, Mechanical, Software or Biomedical Engineering or other relevant technical area with 6 to 7 years of experience, where 4 of those years are progressive experience in software development or lifecycle management.


• Or MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management. 


• Ability and skill to effectively manage multiple tasks and lead execution of change management plans


• Ability and skill to handle the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root cause analysis tools and project management techniques 


• Ability to effectively write communications that ensure clarity, accuracy and consideration of the audience 


• Ability to speak with clarity and express points of view in a variety of settings: one-on-one interactions, group meetings, and formal presentations 


• Ability to listen to others, including associates, managers, peers and customers, when making decisions and solving problems 


• Ability and skill to analyse using systematic analysis tools that include root cause, failure analysis and risk assessment to gather critical information and diagnose 


• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution 


• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO).