Quality Engineer 3 - Risk Management (Medical Devices)

Location: San Diego, CA, United States

Annual base salary: $98,500–$154,000, plus bonus eligibility.

Company

hirify.global develops medical device and in-vitro diagnostic products and provides regulated healthcare technologies.

What you will do

• Perform and maintain product and process risk management activities across product development, manufacturing, sustaining, and post-market lifecycles.
• Develop, review, and maintain risk management files, hazard analyses, FMEAs, safety risk analyses, and benefit-risk evaluations.
• Assess changes to products, processes, software, suppliers, manufacturing, services, and labeling for new or affected risks.
• Identify, verify, and evaluate the effectiveness of risk controls and support design reviews, change boards, CAPA teams, complaint investigations, and material review activities.
• Provide technical input for internal and external audits, regulatory inspections, supplier audits, and inspection readiness.
• Collaborate with Quality, Regulatory Affairs, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post-Market teams.

Requirements

• Bachelor’s degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline.
• 5+ years of experience in a regulated medical device, IVD, quality engineering, or product development environment.
• Experience with risk management files, hazard analyses, FMEAs, design controls, change control, complaints, CAPA, and/or nonconformances.
• Knowledge of FDA Quality System requirements, ISO 13485, ISO 14971, QSR, CDRH, IVDR, MDR, MDSAP, and IEC 62304 requirements.
• Experience evaluating post-market information and maintaining risk files through product development, manufacturing, and post-market surveillance.
• Ability to produce technically accurate, inspection-ready documentation and apply root cause analysis, problem-solving, and risk-based decision-making.

Culture & Benefits

• Comprehensive onboarding training and continued professional development throughout the career.
• Work in a regulated environment focused on compliance, inspection readiness, continuous improvement, and product safety.
• Annual base salary of $98,500–$154,000 with bonus eligibility.