Sr Software Quality Engr - Exempt

Actalent•Memphis, TN

28d•$60 - $60•Onsite

About The Position

The role of the SR. Software Quality Engineer involves managing supplier quality activities related to software and software-embedded components. This position requires technical expertise in software engineering combined with supplier quality management to ensure suppliers meet regulatory compliance and performance standards. You will act as a vital link between suppliers' engineering teams and quality systems.

Requirements

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, including IEC, ISO 9001, and FDA guidelines.
Experience working with suppliers or external partners in a technical or quality capacity.
Excellent communication, auditing, and documentation skills.

Nice To Haves

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

Responsibilities

Provide oversight on software updates and deployments at suppliers, ensuring alignment with IEC 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 and Multi-Language package level assemblies, and MATNR releases.
Support labeling updates, including labels, manuals, and subassemblies for new markets and product expansions.
Drive supplier quality activities related to component obsolescence projects, such as Murata DC-DC converter replacement and accessory qualification for remote controls, cables, and 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 metrics contributing to continuous improvement and supplier performance.