Senior Supplier Software Quality Engineer – Medical Device

Senior Supplier Software Quality Engineer – Medical Device Job Title:

Sr. Software Supplier Quality Engineer - Medical Device

Location:

Memphis, TN (Onsite)

Duration:

12 Months

We’re seeking a

Senior Software Quality Engineer

to manage supplier quality activities for

software and software-embedded components . The ideal candidate will ensure compliance with

ISO 13485, IEC 62304, and FDA regulations , driving quality across suppliers and engineering teams.

Key Responsibilities

Oversee supplier software validation, documentation, and compliance.

Conduct supplier software audits and manage CAPA activities.

Lead qualification of software updates, assemblies, and labeling changes.

Collaborate cross-functionally to ensure supplier performance and lifecycle integration.

Required Skills

Software Quality Engineering

Supplier Quality Management

Software Validation & SDLC

Preferred

Medical Device or Pharma experience

Six Sigma Green Belt

Familiarity with software cybersecurity compliance

Seniority level Mid-Senior level

Employment type Contract

Job function Engineering, Education, and Manufacturing

Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Engineering Services

#J-18808-Ljbffr