Senior Quality Engineer

We have a current opportunity for a Senior Quality Engineer as a contractor with opportunity to extend.

Location:

Irvine (hybrid option)

Medical Device – Class III | Design Quality & Risk Management

As we transition from rapid development into formal FDA design controls, we are seeking a hands‑on Risk Management Subject Matter Expert (SME) to lead risk management remediation efforts, establish a compliant risk‑management framework, and support transfer of legacy design documentation from our China team.

This contractor will play a critical role in aligning our risk processes with FDA's latest Quality Management System Regulation (QMSR) expectations, laying the groundwork for future ISO 14971 adoption, and ensuring our Design History File (DHF) is audit‑ready in risk management domain.

• Establish a scalable, compliant risk management framework
  , including procedures, templates, and traceability structure.
• Build the foundational infrastructure needed for future ISO 14971 adoption (full implementation not required but alignment is expected).
• Lead remediation of existing risk management files to align with FDA's updated QMSR expectations.
• Conduct hazard identification, risk analysis, and risk control evaluation for Class III devices with Software.
• Ensure full traceability across hazards, mitigations, design outputs, verification activities, and residual‑risk assessments.

• Review, assess, and remediate transferred legacy risk documents.
• Provide clear cross‑functional guidance on documentation adequacy, required updates, and compliance expectations.
• Consolidate disparate or incomplete historical records into a coherent, audit‑ready risk management file.
• Serve as the primary technical expert on risk management for Design, Quality, and Regulatory teams.

• Partner with R&D to translate legacy development work into compliant design inputs, outputs, and verification evidence.
• Identify design documentation gaps that affect risk management integration.
• Support DHF structure, change control, and documentation remediation to ensure consistency and compliance.

Qualifications

Must Have

• 7+ years experience in Medical Device Quality or R&D with a specialization in risk management
  .
• Demonstrated ownership of ISO 14971‑based risk management for complex (Class II or III) devices with Software.
• Hands‑on experience creating or remediating risk frameworks, procedures and technical files.
• Deep familiarity with FDA Design Controls, QSR/QMSR, and risk‑based decision processes.
• Experience supporting regulatory submissions or inspections where documentation involving documentation gaps.
• Proven ability to work autonomously in a fast‑paced, dynamic environment.

Preferred

• Experience supporting global design transfers, especially between U.S. and China teams.
• Knowledge of electrophysiology, catheter‑based systems, or similar high‑risk devices.

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.

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