Website Artech LLC
Artech LLC
Company : Artech LLC
Job Title: Sr. Software Quality Engineer
Job ID: 22246
Location: Memphis, TN (Onsite)
Duration: 12 Months
Pay Rate: $55.00 – $60.00/hr (W2)
Job Summary:
The Supplier Quality Software Engineer (SQSE) will oversee supplier quality activities related to software and software-embedded components. The role bridges software engineering, supplier management, and regulatory compliance, ensuring that suppliers meet all quality and performance standards per medical device regulations.
Key Responsibilities:
-
Provide supplier quality oversight for software updates and deployments aligned with ISO 13485, IEC 62304, and FDA requirements.
-
Review and approve supplier software documentation (validation plans, PPAPs, risk assessments).
-
Lead qualification of new and updated software versions and product releases.
-
Support labeling updates and market expansion activities.
-
Manage supplier quality aspects of component obsolescence and accessory qualification projects.
-
Conduct software and supplier quality audits</strong>; drive corrective and preventive actions.
-
Collaborate cross-functionally with Engineering, Regulatory, and Operations teams.
-
Track supplier quality metrics and support continuous improvement initiatives.
Must-Have Skills:
-
Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related field.
-
3+ years’ experience in Software Quality, Validation, or Supplier Quality Engineering.
-
Strong understanding of Software Development Life Cycle (SDLC) and software validation practices.
-
Knowledge of ISO 13485, ISO 9001, IEC 62304, and FDA regulations.
-
Hands-on experience with supplier or external partner quality management.
-
Excellent communication, auditing, and documentation skills.