Senior Director, Quality - Medical Devices

Location: Round Lake, Illinois, United States; travel up to 40% to manufacturing sites and vendors.

Salary: $216,000–$297,000 annually, plus potential discretionary bonuses, commission, and/or long-term incentives.

Company

hirify.global develops healthcare products and medical devices focused on improving outcomes for patients and healthcare providers.

What you will do

• Develop and execute a multi-year Quality strategy across the medical device network.
• Lead Quality governance, risk-based decision-making, compliance, and inspection readiness across multiple sites and functions.
• Provide executive oversight of Design Quality, Manufacturing Quality, and Post-Market Surveillance across the product lifecycle.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, Finance, HR, and Commercial leaders on product development, transfers, lifecycle management, and reliable supply.
• Drive quality transformation, remediation, continuous improvement, and operational excellence initiatives.
• Build, coach, and develop quality leaders while strengthening succession planning and organizational capability.

Requirements

• 15+ years of progressive Quality leadership experience in the medical device industry.
• Bachelor's degree in Engineering, Science, or a related discipline required; an advanced degree is preferred.
• Expertise in medical device quality systems, regulatory requirements, inspection management, and risk mitigation.
• Experience leading Design Quality, Manufacturing Quality, and Post-Market Surveillance organizations.
• Knowledge of FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP, and related global regulations and standards.
• Applicants must already be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Advanced degree in a relevant discipline.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Health, dental, life, disability, and business travel accident insurance for eligible employees.
• 401(k) retirement plan with company matching and an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.