Job Title: Engineer, Software Quality - Senior Or Lead
Location (On-site, Remote, or Hybrid?): Irving, TX (onsite)
Contract Duration:12 months contract
Work Hours: 8AM - 5PM

Senior Software Design Quality Engineer

Job Summary:

The position will be providing software quality support for new medical device product development which includes activities and tasks related to the software development lifecycle (SDLC).  Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity.  It is expected to have a firm understanding of the software development lifecycle (SDLC).  It is expected to have a firm understanding of design controls including design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to software product development.  Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.

Main Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

• Design/Change Control - Software responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
• Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
• Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles.  Participates in the development, modification and design review of Protocols, Data Summaries & Records.
• Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
• Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
• Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Quality Engineering – Participates on project teams and technical review boards.  Coordinates quality decisions between different quality and engineering groups.  Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

Accountability/Scope: 
Ability to work in a dynamic & fast paced environment. Ability to work on numerous projects in parallel. Must be a strong communicator with peers, team members, and management. Anticipates the impact and risk of decisions and actions at both the project and organizational level.  Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.

Minimum Qualifications:

B.S. in Computer Science; Software Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience.  MS is preferred.  4+ years experience covering the entire software lifecycle and design control processes in a team-oriented environment.

Preferred Qualifications:

Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.  Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11. Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.