Senior Quality Engineer (Medical Devices)

Location: Onsite in North Chicago, Illinois, United States

Salary: $84,500–$162,000 per year

Company

hirify.global develops medicines, medical devices, combination products, and aesthetic solutions across areas including immunology, oncology, neuroscience, and eye care.

What you will do

• Represent Quality Assurance on cross-functional teams and execute quality system requirements for product transfer, manufacturing, and lifecycle maintenance.
• Perform design control, risk management, design change control, and Design History File activities for medical devices and combination products.
• Lead design transfer activities supporting product launches, including transfers within and outside hirify.global.
• Manage on-market design changes, impact assessments, action plans, and timely closure of related activities.
• Support equipment qualifications, process validations, regulatory submissions, audits, investigations, CAPAs, NCRs, and review boards.
• Identify process gaps and drive quality improvements, including updates to procedures, policies, forms, and other controlled documents.

Requirements

• Bachelor's degree in engineering, science, or another technical field.
• 6+ years of relevant medical device industry experience, including 4+ years in Quality Assurance.
• Strong understanding of regulations and standards for medical devices and combination products, including 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971.
• Practical experience with design control, risk management, product development, requirements definition, and verification and validation specifications.
• Ability to coordinate complex activities, resolve quality problems, communicate requirements, and negotiate across cross-functional teams.
• Onsite work in North Chicago, Illinois, United States.

Nice to have

• Professional accreditation such as ASQ Certified Quality Auditor or Certified Quality Engineer.

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 short-term incentive programs.
• Work with cross-functional and international stakeholders on regulated healthcare products.