Sr Software Quality Engr

Job Description

The Supplier Quality Software Engineer (SQSE) will be responsible for managing supplier quality activities related to software and software-embedded components. This role combines technical expertise in software engineering with supplier quality management, ensuring that our suppliers meet regulatory, compliance, and performance standards. You'll act as the bridge between suppliers, engineering teams, and quality systems.

Key Responsibilities

• Provide SQE oversight on software updates and deployments at suppliers ensuring alignment with ISO 13485, IEC 62304, and FDA regulations.
• Review and approve supplier software documentation, including validation plans, PPAP deliverables, and risk assessments.
• Lead qualification efforts for new and updated software versions (English Only & Multi-Language), package level assemblies, and MATNR releases.
• Support labeling updates (labels, manuals, and subassemblies) for new markets and product expansions.
• Drive supplier quality activities related to component obsolescence projects (e.g., Murata DC-DC converter replacement) and accessory qualification (remote controls, cables, power cords).
• Conduct software and quality audits of suppliers, driving corrective actions where required.
• Partner cross-functionally with Engineering, Regulatory, and Operations to integrate supplier software quality into lifecycle processes.
• Track and report SQE metrics, contributing to continuous improvement and supplier performance.

Qualifications

Required :

Preferred :

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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