Sustaining Quality Director (Medical Devices)

Location: Northfield, Illinois, United States. The position requires business travel of up to 30%, including in-state, out-of-state, and international travel.

Salary: $177,000–$266,000 annual base salary, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare products organization offering quality, regulatory, manufacturing, and product-related career opportunities.

What you will do

• Develop the strategy, operating model, priorities, and governance for the Sustaining Quality organization.
• Lead complex cross-functional remediation and product lifecycle quality programs.
• Establish risk-based portfolio controls covering priorities, resources, milestones, dependencies, and escalation of patient safety and compliance risks.
• Identify systemic gaps revealed through CAPAs, complaints, risk assessments, field actions, and audits, then drive sustainable corrective improvements.
• Partner with Quality, Regulatory Affairs, Research and Development, Product Management, Manufacturing, Operations, and senior leadership to align decisions and execution.
• Oversee inspection and audit readiness, executive reporting, quality-system backlog management, resource planning, and organizational capability development.

Requirements

• Bachelor’s degree in Engineering, Science, Quality, Regulatory Affairs, or a related technical field.
• At least 7 years of experience in medical devices, pharmaceuticals, drug combination products, or another regulated industry.
• At least 4 years of management experience; experience managing through multiple managers and major departments is required.
• Technical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Ability to lead complex cross-functional programs, manage competing priorities, analyze quality data, and support risk-based decisions.
• Advanced communication skills for presenting complex quality, regulatory, and business matters to senior and executive leadership, plus advanced Microsoft Excel proficiency.

Nice to have

• At least 6 years of managerial experience.
• At least 8 years of related experience in medical devices, pharmaceuticals, drug combination products, or regulated healthcare products.
• Experience establishing an enterprise or cross-divisional quality function, remediation program, or operating model.
• Experience leading employees, contractors, and technical subject-matter experts.

Culture & Benefits

• Competitive total rewards package with bonus and/or incentive eligibility.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Inclusive workplace focused on belonging, professional growth, and equal employment opportunity.