Software Design Quality Assurance

3 days ago

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Siemens Healthineers

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Siemens Healthineers is a leading MedTech company focused on pioneering breakthroughs in healthcare. They offer a comprehensive portfolio that addresses the entire care continuum for serious diseases, including medical imaging, laboratory diagnostics, point-of-care testing, and digital health solutions. With a commitment to innovation, sustainability, and improving patient access to care, Siemens Healthineers collaborates with healthcare professionals and organizations globally to advance medical technology and enhance patient outcomes.

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $1.5M Grant on 2021-05

📋 Description

• A member of the Quality and Compliance team responsible for reviewing and approving Design Control documentation and driving improvements in Product Lifecycle processes for standalone software, with a focus on EMR and treatment support software products on a cloud platform • Participating as an independent reviewer on cross-functional teams to review and approve design control documentation, including software design and development plans and related design inputs and design outputs, with emphasis on quality by design. • Partaking in Discrepancy Report Review Board to ensure that product defects/complaints are reviewed, diagnosed and handled in a prompt, consistent and compliant manner. • Analyzing customer complaint data and provide analysis to engineering teams to develop methods, processes, procedures and equipment that will improve the failure analysis process and/or reduce failures. • Identifying improvement opportunities on SOPs and work with cross functional team to implement the changes/updates in processes, procedures, and work instructions. • Reviewing and follow-up on design control process-related audit non-conformances, CAPAs and customer complaints/field problems, to establish a closed-loop system.

🎯 Requirements

• Minimum Qualifications: • BSc in a relevant field (Engineering, Computer Science, Sciences) and 3+ years of experience in a Software Engineering function, or Quality Assurance function, preferably with products operating on a cloud platform • Experience in Software Development, preferably with EMR and treatment support software products • Excellent technical writing and oral communication skills • Ability to plan, organize, and implement concurrent tasks and project • Excellent organizational, problem-solving, and analytical skills • Experience working in a cross-functional team environment • Ability to influence and interact with cross-functional team members • Ability to manage priorities in a fast-paced environment • Proficiency utilizing business tools such as e-mail, Microsoft Word, Excel, and PowerPoint, and other productivity software • The following experience would be considered an asset or the applicant should be willing to acquire on-the-job as follows: Understanding of and/or experience auditing to standards or regulations such as ISO 9001, ISO 13485, ISO 14971, IEC 62304, the FDA Quality System Regulation, Medical Device Directive and/or Canadian Medical Device Regulation • Experience with cybersecurity standards or requirements • Experience in Risk Management