Senior Quality Engineer, Cybersecurity

Jobtailor; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a Quality Lead to drive the Software Quality Management System (QMS) and cybersecurity integration across the SDLC for medical devices. You will guide development teams on DDFs, support ISO 14971 risk management, IEC 62304, and FDA cybersecurity guidance, and align processes with post-market surveillance requirements.

The role requires 5+ years in software quality engineering within FDA QMSR / ISO 13485 environments, proven cross-functional leadership, and experience with

Qualifications

• Bachelor's degree in a related technical field or equivalent practical experience.
• 5+ years in software quality engineering in FDA QMSR / ISO 13485 medical device industry.
• Proven expertise in medical device cybersecurity.
• Experience with FDA premarket/postmarket cybersecurity guidance and standards (e.g., AAMI TIR57).
• Experience applying IEC 62304, ISO 14971, IEC 62366, and AAMI TIR57.
• Experience collaborating with software development and security teams.
• Proficiency in Google Workspace, Jira, GitHub, and document control systems.
• Excellent cross-functional communication, organizational, and leadership skills.

Responsibilities

• Lead ongoing implementation and continuous improvement of the Software Quality Management System (QMS).
• Serve as the Quality Lead for the cybersecurity process.
• Guide software development teams in creation and maintenance of Design and Development Files (DDFs).
• Support ISO 14971 risk management, IEC 62366 usability engineering, and FDA cybersecurity guidance integration into SDLC.
• Support post-market cybersecurity surveillance activities.
• Provide CAPA, complaints, audit, and QMS support related to software and cybersecurity incidents.

Skills

Software Quality Engineering

Medical Device Cybersecurity

Cross-Functional Communication

Leadership Skills

SDLC

DDFs

Collaboration with Security Teams

G Workspace / Jira / GitHub

Education

Bachelor's degree in Computer Science or related field

Tools

Google Workspace

Jira

GitHub

Document Control Systems

Job description

• Lead ongoing implementation and continuous improvement of the Software Quality Management System (QMS)
• Serve as the Quality Lead for the cybersecurity process
• Guide software development teams in creation and maintenance of Design and Development Files (DDFs)
• Support ISO 14971 risk management, IEC 62366 usability engineering, and FDA cybersecurity guidance integration into SDLC
• Support post-market cybersecurity surveillance activities
• Provide CAPA, complaints, audit, and QMS support related to software and cybersecurity incidents

Requirements

• Bachelor's degree in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a related technical field; or equivalent practical experience
• 5+ years in software quality engineering within the FDA QMSR / ISO 13485 medical device industry
• Proven expertise in medical device cybersecurity
• Work experience with FDA premarket and postmarket cybersecurity guidance and applicable standards (e.g., AAMI TIR57)
• Demonstrated experience applying IEC 62304, ISO 14971, IEC 62366, and AAMI TIR57
• Experience collaborating with software development and security teams
• Proficiency in Google Workspace, Jira, GitHub, and document control systems
• Excellent cross-functional communication, organizational, and leadership skills

Core Competencies

Demonstrates expertise in Software Quality Management Systems (QMS) and medical device cybersecurity, with a strong focus on ISO 14971, IEC 62366, and FDA guidance integration into the software development lifecycle. Proven ability to lead cross-functional teams and support compliance in the medical device industry.

Highest-signal resume keywords

• Software Quality Management System (QMS)
• Medical Device Cybersecurity
• ISO 14971 Risk Management
• IEC 62304 Compliance
• FDA Cybersecurity Guidance

ATS Optimization Keywords

Hard Skills

• Software Quality Engineering
• Design and Development Files (DDFs)
• Risk Management
• Usability Engineering
• CAPA Management

Soft Skills

• Cross-Functional Communication
• Organizational Skills
• Leadership Skills

Industry Keywords

• FDA QMSR
• ISO 13485
• AAMI TIR57
• Post-Market Cybersecurity Surveillance
• Software Development Lifecycle (SDLC)

Tools & Technologies

• Google Workspace
• Jira
• GitHub
• Document Control Systems