Quality Engineer - II (Medical Devices)

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

Salary: $79,200–$118,800 per year

Company

Global healthcare technology company developing medical technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Lead complaint investigations, analyze explants and returned products, and conduct periodic complaint trending.
• Evaluate negative trends and product risks to support field-action decisions.
• Collaborate with customer quality, clinical affairs, medical safety, R&D engineering, manufacturing, regulatory affairs, and design assurance teams.
• Prepare complaint data and responses for regulatory inquiries, product registrations, and regulatory submissions.
• Own and maintain periodic safety update reports for applicable devices.
• Improve post-market quality processes and systems, and escalate significant quality issues to leadership.

Requirements

• Bachelor’s degree in engineering, health science, or another technical discipline.
• At least 2 years of engineering or science experience, or an advanced degree in engineering, science, or a technical discipline with no prior experience.
• Experience in a highly regulated industry, preferably implantable medical devices.
• Knowledge of product development cycles, including clinical and regulatory requirements.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this role.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Advanced degree in engineering, science, or an equivalent technical discipline.
• Knowledge of cardiovascular or implant procedures.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account and Healthcare Flexible Spending Account.
• Paid time off, paid holidays, disability coverage, and life insurance.
• 401(k) plan with employer contribution and match.
• Tuition assistance, employee stock purchase plan, incentive plans, and employee assistance program.