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Sr Software Quality Engr - Exempt

Sr Software Quality Engr - Exempt

LanceSoftMemphis, TN, United States
23 hours ago
Job type
  • Full-time
Job description

Join our dynamic team in Memphis, TN, a city known for its vibrant culture, rich history, and thriving tech scene. We are seeking a dedicated professional to enhance our supplier quality activities related to software and software-embedded components. This role is perfect for someone who thrives at the intersection of software engineering and supplier quality management, ensuring compliance with regulatory and performance standards.

Key Responsibilities

  • Provide 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, package level assemblies, and MATNR releases.
  • Support labeling updates for new markets and product expansions.
  • Drive supplier quality activities related to component obsolescence projects and accessory qualification.
  • 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 :

  • Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, or related field.
  • 3 years of experience in software quality, software validation, or supplier quality engineering.
  • Strong understanding of software development life cycle (SDLC) and validation practices.
  • Familiarity with regulatory and quality standards (ISO 13485, ISO 9001, IEC 62304, FDA guidelines).
  • Experience working with suppliers or external partners in a technical / quality capacity.
  • Excellent communication, auditing, and documentation skills.

    • Preferred :

  • Experience in the medical device, pharmaceutical, or highly regulated manufacturing industry.
  • Knowledge of risk management (ISO 14971) and cybersecurity compliance for software.
  • Supplier audit experience (domestic / international).
  • Six Sigma Green Belt or equivalent process improvement certification.
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    Sr Software Quality • Memphis, TN, United States