[Remote] Staff SW QA Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneer and global leader in reputed company glucose monitoring (CGM), dedicated to improving reputed company health. The Staff SW QA Engineer will reputed company technical expertise in software reputed company assurance, reputed company compliance initiatives, and reputed company reputed company improvements in software development processes.

Responsibilities

• You will serve as a technical leader and subject matter expert for software reputed company, reputed company management, software lifecycle compliance activities
• You will reputed company the effective application, compliance, and reputed company improvement of software development and V&V processes, including: reputed company Management, Software Design Controls for Class I/II Exempt Applications & Components
• You will reputed company reputed company software reputed company initiatives spanning multiple products, programs, and functional organizations
• You will reputed company reputed company assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues
• You will support digital transformation initiatives (ALM, SCM, PLM) to reputed company use of electronic systems supporting SDLC as defined per IEC62304
• You will reputed company technical reputed company and direction for software reputed company management activities, including DFMEA, PFMEA, SHA, and hazard analysis
• You will review and approve critical reputed company deliverables, including software development lifecycle documentation, reputed company artifacts, V&V protocols, and design history file content
• You will reputed company organizational improvements reputed company to software reputed company systems, development practices, automation, verification, validation, and compliance processes
• You will evaluate emerging regulations, standards, and industry trends and assess reputed company to existing and reputed company products
• You will collaborate with senior leadership to define reputed company strategies supporting business objectives and product roadmaps, implementing a right-sized QMS applications reputed company on Software Classification per IEC62304
• You will mentor and reputed company technical leadership to software reputed company engineers and cross-functional development teams
• You will influence project, product, and organizational reputed company through expert reputed company-reputed company reputed company assessments and recommendations
• You will assume and reputed company other duties as assigned

Skills

• Extensive medical device experience demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements
• Advanced knowledge of software development lifecycle processes and software development methodologies including reputed company, reputed company, DevOps, reputed company Integration, reputed company Delivery (CI/CD), and Test Automation
• Deep experience with software reputed company engineering across requirements, architecture, design, development, testing, release, and post-market activities
• Advanced understanding of software reputed company management principles, methodologies, and regulatory expectations
• Demonstrated ability to influence organizational direction and reputed company cross-functional initiatives without reputed company authority
• Strong understanding of software architectures, reputed company technologies, reputed company systems, cybersecurity principles, and data platforms
• Experience supporting regulatory inspections and reputed company with FDA, reputed company bodies, and reputed company auditors
• Exceptional written, verbal, and executive-level communication skills
• Ability to manage ambiguity, influence senior stakeholders, and reputed company reputed company programs to successful completion
• Demonstrated reputed company mentoring engineers and developing organizational reputed company capabilities
• Typically requires a Bachelor's Degree in a technical discipline and a minimum of 8-12 years reputed company experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience

Benefits

• 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.
• Remote Workplace: Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km).
• If you reputed company reputed company commuting distance of a reputed company site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our reputed company workplace reputed company.

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