SVP Quality Systems (MedTech)

Location: Northfield, Illinois, United States; up to 50% domestic and international business travel required.

Salary: $309,000–$464,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare products organization providing quality, regulatory, and operational solutions in a highly regulated environment.

What you will do

• Provide executive leadership and governance for the global Quality Management System across sites and business units.
• Define, harmonize, govern, and continuously improve common quality processes with Global Process Owners.
• Oversee post-market surveillance, including complaint handling, signal detection, trending, adverse event reporting, and risk-management integration.
• Lead the quality technology strategy covering enterprise quality systems, quality data, analytics, AI, and automation.
• Ensure quality systems are selected, implemented, validated, maintained, and improved in line with business and regulatory needs.
• Develop senior leaders, establish accountability and performance standards, and partner with Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, IT, Commercial, and business leadership.

Requirements

• Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or a related field.
• At least 15 years of progressively responsible experience in Quality Assurance, Regulatory Affairs, Quality Engineering, or a related function within medical devices, pharmaceuticals, healthcare products, or another highly regulated industry.
• At least 10 years of people-leadership experience, including leadership of senior leaders and complex multi-site or global organizations.
• At least 5 years of executive-level experience at Vice President level or above with responsibility for enterprise outcomes, cross-functional execution, organizational capability, and succession planning.
• Deep knowledge of FDA requirements, ISO 13485, EU MDR, and other global quality and regulatory requirements.
• Strong executive communication, influencing, negotiation, stakeholder management, analytical, risk-management, problem-solving, and decision-making skills.

Nice to have

• Master’s degree in Engineering, Quality Management, Regulatory Affairs, Life Sciences, Business, or a related field.
• Relevant professional quality or regulatory certification.
• Experience in a complex global healthcare products organization.

Culture & Benefits

• Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off.
• Continuing education and training opportunities.
• Bonus and/or incentive eligibility.
• Focus on diversity, inclusion, belonging, career growth, and access to tools and resources for effective work.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.