Design Quality, Late-Stage Development Manager (Medical Devices)

Location: North Chicago, Illinois, United States; onsite

Salary: $109,500–$208,500 per year

Company

hirify.global develops innovative medicines and healthcare solutions across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead quality and compliance activities for new product introduction combination products and medical devices.
• Guide design control activities, design reviews, requirements traceability, design changes, and product risk assessments.
• Develop and implement quality assurance strategies for products manufactured by hirify.global sites, suppliers, and contract manufacturers.
• Lead cross-functional initiatives to identify process gaps, develop solutions, and resolve quality-related issues.
• Support regulatory inspections, internal audits, supplier audits, due diligence, and pre-approval inspection readiness.
• Manage relationships and quality agreements with suppliers, contract manufacturers, plants, affiliates, and other stakeholders.

Requirements

• Bachelor’s degree in engineering, life science, another technical discipline, or equivalent experience.
• 7+ years of total combined experience, including at least 5 years in Operations Quality Assurance.
• Comprehensive knowledge of combination products, medical devices, manufacturing processes, and applicable regulations and standards.
• Practical experience with product development, design control, requirements definition, verification, validation, and risk management.
• Strong analytical, problem-solving, leadership, communication, and negotiation skills.
• Ability to work independently, manage multiple complex tasks, and collaborate in global cross-functional teams.

Nice to have

• Experience with root cause investigations, CAPA, statistics, and data analytics.
• Experience in Operations, Research and Development, or consulting.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.