Quality Engineer II (Medical Devices)

Location: Rice Creek, Minnesota, United States; onsite 5 days per week. Travel expected at 15% or less. Candidates must have unrestricted U.S. work authorization at hire and throughout employment.

Salary: $79,200–$118,800 per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops medical technologies designed to alleviate pain, restore health, and extend life.

What you will do

• Support quality system compliance and operational objectives across service center and field service activities.
• Develop and maintain quality standards, procedures, controls, and performance metrics.
• Provide quality oversight for validation, verification, nonconformance management, CAPA, and change control.
• Investigate quality issues, assess risk, and implement effective corrective actions.
• Assess suppliers, manage supplier corrective actions, and verify compliance with GMP and ISO requirements.
• Support internal and external audits and lead quality walks and continuous improvement initiatives.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 2+ years of engineering or quality experience, or an advanced degree with 0+ years of experience.
• Experience or knowledge in quality systems, CAPA, nonconformance management, root cause investigation, and corrective actions.
• Knowledge of supplier quality, process validation, verification, and quality data analysis.
• Ability to collaborate across engineering, regulatory, supplier quality, post-market quality, and operating functions.
• Ability to work onsite in Rice Creek, Minnesota, five days per week.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this role.

Nice to have

• Quality System Lead Auditor experience with ISO 13485.
• Working knowledge of ISO 14971 and medical device risk management.
• Experience in medical devices or another regulated industry.
• Experience supporting service, repair, manufacturing, operations, or internal and external audits.
• Familiarity with continuous improvement methodologies and quality performance reporting.

Culture & Benefits

• Purpose-driven work focused on improving patient health through medical technology.
• Health, dental, and vision insurance for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Health Savings Account, Flexible Spending Account, life insurance, disability coverage, and dependent-care support.
• Tuition assistance, employee stock purchase plan, incentive plans, and well-being resources.