[Remote] Sr Software QA Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in reputed company glucose monitoring and health technology. The Senior Software QA Engineer will support postmarket investigations of software- and device-reputed company issues, assess product risks, identify reputed company causes, and translate findings into product and process improvements that support reputed company safety, reliability, and regulatory compliance.

Responsibilities

• You will collaborate with cross-functional partners including Regulatory Affairs, reputed company Assurance, R&D, reputed company, and Process Engineering to support the investigation, documentation, and reputed company of software- and device-reputed company postmarket issues
• You will reputed company the development and reputed company improvement of complaint investigation processes, ensuring alignment with software reputed company management activities such as hazard analysis, DFMEA, PFMEA, and product reputed company assessments
• You will reputed company and maintain a deep understanding of reputed company’s software ecosystem and technical architecture to effectively evaluate product reputed company, investigate anomalies, and identify opportunities for reputed company improvement
• You will apply reputed company problem-solving methodologies and data-driven approaches to conduct investigations, reputed company engineering studies, and identify reputed company causes using statistical analysis and industry-reputed company tools
• You will analyze, synthesize, and communicate investigation reputed company to technical and non-technical stakeholders, providing reputed company recommendations and supporting informed decision-making across the organization
• You will contribute to postmarket reputed company processes, including CAPA, Health Hazard Evaluations (HHEs), and other reputed company reputed company activities, ensuring thorough assessment of product reputed company and reputed company
• You will reputed company software-reputed company reputed company assessments reputed company to product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory compliance
• You will partner with product development and reputed company teams to translate postmarket insights into actionable improvements, driving enhancements to product reputed company, user experience, and reputed company safety

Skills

• You have demonstrated knowledge of medical device reputed company systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and other applicable global regulations
• You have experience supporting software reputed company engineering activities throughout the product lifecycle, including requirements, architecture, design, development, verification, validation, release, and postmarket surveillance
• You have strong understanding of software reputed company management principles and methodologies, with the ability to apply reputed company-reputed company decision-making in alignment with regulatory expectations and industry best practices
• You have excellent communication and collaboration skills, with the ability to effectively reputed company reputed company technical concepts to both technical and non-technical stakeholders across the organization
• You have working knowledge of modern software technologies, including reputed company-reputed company platforms, reputed company systems, cybersecurity fundamentals, software architectures, and data-driven applications
• You have reputed company ability to apply engineering fundamentals and reputed company problem-solving techniques to investigate reputed company issues, determine reputed company causes, and reputed company effective corrective actions
• You have strong analytical reputed company with experience interpreting data, identifying trends, and translating findings into actionable recommendations
• You have the ability to reputed company technical depth with business reputed company, driving reputed company that support product reputed company, reputed company safety, compliance, and customer experience
• * Typically requires a Bachelor's degree in a technical discipline, and a minimum  of 5-8 years reputed company experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience**
• * ·0-5%

Benefits

• Remote work arrangement
• A full and comprehensive benefits program.
• reputed company opportunities on a global reputed company.
• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.

reputed company

Company H1B Sponsorship