Lead Digital Health Quality Engineer (SaMD)

Location: North Chicago, Illinois, United States

Salary: $96,500–$183,500 per year

Company

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

What you will do

• Represent quality on cross-functional Software as a Medical Device (SaMD) and Digital Health product development teams.
• Drive design controls, risk management, cybersecurity risk activities, and Design History File management throughout the software lifecycle.
• Author, review, and approve QMS, project, validation, and risk management documentation.
• Support regulatory submissions, internal audits, and regulatory agency audits.
• Lead CAPA activities, root-cause analysis, effectiveness checks, and continuous quality improvement initiatives.
• Report project and quality status, advise management, and resolve emerging quality issues.

Requirements

• Bachelor’s degree with 6 years of experience, master’s degree with 5 years, or PhD with 0 years of experience.
• Experience working in a quality systems environment and coordinating complex activities across cross-functional teams.
• Strong understanding of software medical device regulations and standards, including IEC 62304, ISO 14971, 21 CFR 820.30, and EU MDR.
• Experience creating and maintaining QMS documentation for medical device development.
• Experience with Computer Software Assurance and GAMP 5 principles for software validation and lifecycle activities.
• Strong analytical, judgment, consulting, communication, and technical writing skills.

Nice to have

• Familiarity with medical device cybersecurity, AI/ML, connected devices, and emerging Digital Health technologies.

Culture & Benefits

• Paid 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.
• Focus on integrity, innovation, community service, and cross-functional collaboration.