Software Quality Engineer

CSV / Software Quality Engineer

Job Description

Join a leading medical device manufacturer as a Software Quality Engineer, where you will play a critical role in implementing three new software and hardware technologies aimed at enhancing defect detection during the manufacturing process. This position is dedicated to projects that bring new manufacturing technologies through the quality and validation process, supporting Real Time Release (RTR) within the manufacturing quality system.

Responsibilities

• Serve as the dedicated Software Quality Engineer supporting new manufacturing technologies.
• Create and execute validation strategies in partnership with the validation engineering team.
• Ensure full software lifecycle compliance for manufacturing applications.
• Apply risk-based thinking to software and system validation activities.
• Review and approve development of lifecycle and validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Validation documentation, Failure Modes and Effects Analysis (FMEA), Traceability Matrices, Development Reports, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure traceability across requirements, risks, testing, and validation evidence.
• Support CSV activities for 5–6 new IT/OT applications, ensuring alignment with internal medical device quality system requirements.
• Support validation execution, deviation handling, and validation closure.
• Collaborate with engineering and automation teams on software-enabled equipment validation.
• Support systems interfacing with PLCs and manufacturing hardware.
• Support change control activities, reviewing and assessing software and system changes for validation and quality impact.
• Ensure appropriate documentation, testing, and approvals are completed prior to release.

Essential Skills

• Bachelor’s degree in Engineering, Computer Science, or related technical discipline.
• Minimum 4 years of experience in Quality, specifically in validation or Computer System Validation (CSV).
• Experience within medical device quality systems.
• Strong understanding of the Software Development Lifecycle (SDLC), CSV, and validation documentation and execution.
• Experience supporting software used in manufacturing or production environments.
• Ability to work independently on long-term, dedicated projects.

Additional Skills & Qualifications

• Experience with IT/OT systems in manufacturing environments.
• Familiarity with PLC integrated systems.
• Experience with Software Validation / Quality on PC-based applications and C++ software.
• Prior experience supporting Real Time Release (RTR) initiatives.
• Experience in equipment validation.

Work Environment

This is a hybrid role, requiring three days on-site and two days off-site. The work environment includes collaboration with engineering and automation teams, and involvement in validation activities for manufacturing software and equipment.

This is a Contract position based out of Jacksonville, FL.

The pay range for this position is $60.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Jacksonville,FL.

This position is anticipated to close on Feb 27, 2026.