Staff Software Quality Engineer

Key responsibilities

Software life cycle quality

• Own quality oversight of the software development lifecycle per IEC 62304, including software safety classification, development planning, requirements, architecture, verification and release
• Review and approve software plans, requirements, design documents, traceability matrices, test protocols and reports, and anomaly lists
• Define and continuously improve software quality procedures and work instructions within the QMS, keeping them practical for Agile and CI/CD teams
• Ensure complete, audit-ready design history file (DHF) content for software

Risk management

• Lead software risk analysis per ISO 14971 IEC 62304, including software hazard analysis, failure modes and SOUP/OTS risk assessment
• Ensure risk controls implemented in software are traced to requirements and verified

Verification and validation

• Guide verification strategy across unit, integration and system levels, including test automation and coverage expectations
• Drive validation of software used in production, the QMS and data integrity (CSV/CSA, 21 CFR Part 11)

Cybersecurity

• Partner with engineering on medical device cybersecurity, including threat modeling, SBOM management, vulnerability monitoring and FDA premarket cybersecurity documentation (IEC 81001-5-1, AAMI TIR57)

Regulatory and compliance

• Prepare software documentation for 510(k), De Novo, PMA and EU IVDR/MDR submissions; respond to agency questions
• Represent software quality in FDA inspections, notified body audits and internal audits
• Keep the organization current on evolving standards and guidance, including the FDA QMSR (ISO 13485 alignment) and AI/ML-enabled device software guidance

Post-market and continuous improvement

• Lead software-related CAPAs, nonconformances, complaint investigations and root cause analysis
• Assess software changes for regulatory impact and manage field updates and patches
• Define and report software quality metrics (escaped defects, CAPA cycle time, audit findings)

Leadership

• Mentor quality and software engineers; train teams on 62304, 14971 and good documentation practice
• Act as a trusted advisor to engineering leadership on quality strategy and risk-based tradeoffs

Required qualifications

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering or a related technical field
• 10+ years in software quality, software engineering or software V&V, with at least 6 years in a regulated medical device or IVD environment
• Deep working knowledge of IEC 62304, ISO 14971, ISO 13485 and 21 CFR 820 (QMSR)
• Hands-on experience authoring or approving software DHF content for FDA submissions (510(k), De Novo or PMA)
• Experience with software validation (CSV/CSA) and 21 CFR Part 11 / data integrity
• Proven record leading CAPAs, root cause investigations and audit responses
• Solid technical fluency: able to read code, review architecture and challenge test strategy credibly with engineers
• Clear writer and communicator who can influence without authority across functions

Preferred qualifications

• Master's degree in a technical field and 5 years medical device experience;
• Experience with IVD instruments, assay analysis software or life science tools (e.g., proteomics, genomics, lab automation)
• EU IVDR/MDR technical documentation and notified body experience
• Medical device cybersecurity experience (FDA premarket guidance, IEC 81001-5-1, SBOM, threat modeling)
• Experience with Software as a Medical Device (SaMD), cloud-hosted software or AI/ML-enabled device software
• Familiarity with Agile in regulated settings (AAMI TIR45) and tools such as Jira, Jama/Polarion, Git and CI/CD pipelines
• Test automation background (e.g., Python, pytest, Robot Framework)
• Certifications such as ASQ CSQE, CQE or CQA, or ISO 13485 Lead Auditor

Desired Skills and Experience

Bachelor's or Master's degree in Engineering, Computer Science, Software Engineering, or related field. 8+ years of experience in Software Quality, Design Assurance, Software Validation, or Quality Engineering within the medical device, diagnostics, or regulated healthcare industry. Experience supporting software development under FDA and international regulatory requirements.

Strong knowledge of IEC 62304, ISO 13485, FDA 21 CFR Part 820, and risk management principles. Experience with software verification and validation activities, requirements traceability, defect management, and SDLC processes. Ability to work cross-functionally with software engineering, systems engineering, regulatory affairs, and quality teams.

Experience with Agile software development methodologies preferred.

EOE Statement

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com