Software Quality Engineer

Primary Talent Partners has a new contract opening for a Sr Software Quality Engr - Exempt with our medical device client in Memphis, TN. This is an 11-month contract with a potential for extension.

Pay: $55.00 - $60.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.


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:

• 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.

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.
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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