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 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).