Lead Risk Management Quality Engineer

Quick Facts

• Role: Lead Risk Management Quality Engineer
• Focus: Risk management across medical device product development and lifecycle

Description

The Lead Risk Management Quality Engineer leads risk management activities across product development and lifecycle management. The role plans, executes, and maintains risk management files to ensure compliance with applicable standards and regulations and alignment with the quality system. You will collaborate with cross-functional teams to identify, assess, and mitigate product risks, supporting design reviews and post-market surveillance.

Responsibilities

• Facilitate risk analyses (e.g., FMEA and hazard analysis)
• Review design and process changes for risk impact
• Provide guidance and training on risk management processes and tools
• Support internal and external audits
• Contribute to continuous improvement initiatives
• Support safety, performance, and reliability through robust risk management

Requirements

• Strong risk management and quality engineering experience (FMEA, hazard analysis, risk control strategies, lifecycle risk documentation)
• Knowledge of medical device regulations and standards (ISO 14971, ISO 13485, FDA QSR, EU MDR)
• Proficiency with quality systems and tools (CAPA, change control, design controls, root cause analysis)
• Ability to interpret design inputs, specifications, test methods, and manufacturing processes
• Cross-functional collaboration skills, including leading risk workshops and influencing stakeholders
• Ability to manage multiple projects and deliver high-quality work in a regulated environment
• Bachelor’s degree in Engineering/Science or related field; advanced degree and certifications (CQE, CQA, RAC) are a plus