Senior Quality Engineer (Medical Devices)

Location: North Chicago, Illinois, United States

Salary: $78,500–$141,000 per year

Company

hirify.global develops medicines, medical devices, and combination products across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Represent Quality Assurance on cross-functional teams supporting medical device and combination product design transfer and change management.
• Lead design transfer activities for product launches within and outside hirify.global.
• Perform design control, risk management, traceability, and Design History File activities.
• Support equipment qualifications, process validations, regulatory submissions, and supplier design control reviews.
• Own on-market design change plans, impact assessments, action plans, and timely closure.
• Lead or support audits, investigations, CAPAs, NCRs, review boards, and continuous improvement initiatives.

Requirements

• Bachelor's degree, preferably in Biology, Chemistry, or Engineering.
• 6+ years of experience in Manufacturing, Quality, or Engineering.
• Knowledge of quality and compliance management, regulations, and standards affecting API, bulk drug, or finished goods manufacturing.
• Strong verbal and written communication, problem-solving, analytical, interpersonal, and negotiation skills.
• Knowledge of global regulations, guidance, corporate standards, and quality systems for medical devices and combination products.

Culture & Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for short-term incentive programs.
• Equal opportunity employment and reasonable accommodation support.