Director Global Quality Management System (Medical Devices)

Location: Libertyville, Illinois, US

Salary: $162,000–$230,000 yearly base pay, plus eligibility for the hirify.global Corporate Bonus Plan.

Company

hirify.global is an independent, employee-owned healthcare products company developing, manufacturing, and marketing ostomy care, continence care, and critical care products worldwide.

What you will do

• Develop, implement, and sustain a harmonized global Quality Management System across organizational sites.
• Lead governance, standardization, and continuous improvement for CAPA, non-conformances, document control, QMS training, internal audits, management reviews, metrics, and trending.
• Oversee enterprise-wide QMS software solutions and validation, quality plans, change control, risk management, and systemic issue investigations.
• Partner with site and regional QMS/QA leads to implement global processes, share best practices, and maintain effective communication.
• Lead regulatory inspection readiness and provide support for interactions with notified bodies and regulatory agencies.
• Define the global QMS strategy, budgets, resources, performance metrics, talent development, and succession planning.

Requirements

• Bachelor’s degree with 12–15 years of related experience.
• At least 5 years of experience in a medical device environment, with extensive medical-device experience required.
• Hands-on experience managing and implementing QMS, CAPA, non-conformances, internal audit programs, QMS software, and software validation.
• Experience with US and international quality regulations and standards, including FDA cGMP, 21 CFR Part 820, ISO 13485, ISO 14971, and MDD/MDR.
• Experience managing external audits and FDA inspections, including representing a company before notified bodies and regulatory agencies.
• Experience with statistical sampling plans based on risk management, continuous improvement, root-cause problem solving, change management, and project execution.
• Management experience leading talent and performance with direct and indirect reports in a global, matrixed organization.
• Strong analytical, communication, interpersonal, fiscal management, cross-functional collaboration, and problem-solving skills.
• Strong Microsoft Office skills, especially Excel; ERP system knowledge is preferred.

Nice to have

• MBA or MS degree.
• Green Belt certification and knowledge of Lean and Six Sigma methodologies.
• ASQ CQM, CQE, CRE, or CQA certification.

Culture & Benefits

• Medical, prescription, dental, vision, disability, life, accident, wellness, and voluntary benefit programs.
• Company-paid parental and caregiver leaves, statutory leaves or disability programs, and paid time off including 11 holidays.
• 401(k) plan with auto-enrollment, Roth option, vesting, and eligible safe-harbor matching contributions.
• Education assistance, adoption assistance, and participation in the corporate bonus plan.
• Work includes high-level decision-making, resource allocation, compliance and risk oversight, and collaboration across departments and sites.