Senior Software Quality Engineer

Senior Software Quality EngineerAbout Your New Employer:Offers a comprehensive range of medical products, devices, and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.Provides a dynamic and innovative work environment with a focus on continuous improvement and quality assurance.Committed to developing high-quality software products that meet stringent regulatory standards.About Your New Job as Senior Software Quality Engineer:Develop, enhance, and maintain strategies and plans to improve the overall quality of software, including test coverage and system performance.Provide strategic and tactical support of the Quality Engineering Function, based on an understanding of 21 CFR Part 820 and ISO Requirements.Own and facilitate the Design Review and Functional Review Process for software products.Collaborate with Manufacturing and R&D to support software products, driving design improvements and monitoring measurable enhancements. Routinely interact with multifunctional groups.Ensure 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.Play 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.Remediate software-related audit findings and CAPAs.What Skills You Need as Senior Software Quality Engineer:Bachelor’s degree in Electrical, Mechanical, Software, or Biomedical Engineering or other relevant technical area6 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).What’s on Offer:Competitive salary and benefits package.Opportunities for professional growth and development.A collaborative and innovative work environment focused on quality and continuous improvement.What’s NextApply now by clicking the “Apply Now" button or call me, Karolina, on 091749267. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.