Senior Quality Engineer (Medical Devices)

Location: Santa Ana, California, United States; on-site presence required 4 days per week. Remote candidates are not accepted.

Salary: $98,400–$147,600 USD per year, plus eligibility for a short-term incentive plan.

Company

hirify.global is a global healthcare technology company developing medical technologies across more than 150 countries.

What you will do

• Lead complex complaint investigations, product performance assessments, root cause analyses, and corrective actions for released products.
• Drive complaint trending, signal detection, risk assessments, and evaluation of patient and business impact.
• Support regulatory submissions, product registrations, health authority inquiries, audits, PSURs, and post-market clinical follow-up activities.
• Partner with Regulatory Affairs, Clinical Affairs, Medical Safety, R&D, Manufacturing, Design Assurance, Risk Management, and Global Quality.
• Improve quality-system effectiveness, operational efficiency, and post-market surveillance processes.
• Provide technical leadership, mentoring, and recommendations to management and executive stakeholders.

Requirements

• Must work on site in Santa Ana, California, 4 days per week; remote work is not available.
• Bachelor’s degree in engineering, health science, or a technical discipline.
• At least 4 years of relevant experience, or a master’s degree with at least 2 years of relevant experience, or a PhD with no required experience.
• Experience with post-market surveillance, complaint handling, risk management, product performance monitoring, statistical analysis, and data trending.
• Experience in a highly regulated industry, preferably implantable medical devices.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this role.

Nice to have

• Advanced degree in engineering, science, or an equivalent technical discipline.
• Knowledge of cardiovascular or implant procedures.
• Experience with product development cycles, clinical requirements, and regulatory requirements.
• Experience leading cross-functional projects and process improvement initiatives.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, and paid sick time where applicable.
• 401(k) plan with employer contribution and matching.
• Tuition assistance, employee stock purchase plan, employee assistance program, and well-being resources.