Supplier Quality Engineer II (Medical Devices)

Location: Remote within the United States; preference for the Midwest. Travel of up to 15% is required for supplier visits, audits, business reviews, and cross-functional activities.

Salary: $80,000–$120,000 per year.

Company

hirify.global develops medical technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Manage supplier quality relationships with contract manufacturers, OEMs, and sub-tier suppliers.
• Support product and process changes through quality planning, risk assessment, validation, and change control.
• Monitor supplier quality performance and lead improvement initiatives addressing quality, delivery, and compliance.
• Conduct supplier audits, assessments, and business reviews.
• Investigate quality issues, facilitate root cause analysis, and drive corrective and preventive actions.
• Review supplier quality documentation and collaborate with R&D, Quality, Regulatory, Operations, and Manufacturing teams.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field with 2+ years of Engineering and/or Quality experience, or an advanced degree with 0+ years of experience.
• Experience in the medical device, pharmaceutical, biotechnology, or another highly regulated industry.
• Knowledge of supplier quality systems, audits, CAPA, change management, and regulated manufacturing environments.
• Knowledge of root cause analysis, continuous improvement tools, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for this role.
• For 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

• Experience supporting contract manufacturers, OEMs, or external supplier networks.
• Experience conducting supplier audits and leading supplier quality improvement initiatives.
• Certification as a Quality Engineer, Auditor, or related quality professional certification.

Culture & Benefits

• Remote work within the United States with up to 15% travel.
• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and disability benefits.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance, incentive plans, employee stock purchase plan, and employee assistance program.