Supplier Quality Engineer in Memphis

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Job Description

NO 3RD PARTY - UNABLE TO SPONSOR - US OR GREEN CARD ONLY

Work Location:

1800 Pyramid Pl Bldg C

Memphis Tennessee 38132

Duration: 12 months

TARGET rates: 55-60/hr

Nice To Have

• 5+ years of application testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical ), or 2+ years of experience with additional advanced degree.

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-), 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:

• 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.

:

• 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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