Jobs › AbbVie

Lead Digital Health Quality Engineer

AbbVie · North Chicago, IL · Full time · Information Technology

Posted Aug 31, 2026 · We last checked this listing on Oct 6, 2026

Apply at AbbVie

Likely interview questions for this role

Written from this job description, not a generic list. Each one notes what the interviewer is really checking.

About your past

The posting says you initiate assignments independently with considerable latitude. Tell me about a quality improvement you started yourself.

What they are checking: Whether they spot quality gaps and start improvements on their own, which is the independence this role expects of a lead engineer.

How do you explain a quality requirement to a software engineer who has never worked under one?

What they are checking: Whether they can explain quality requirements to developers in practical terms, so engineers see them as protecting patients rather than paperwork.

What would you do

A development team wants to ship on a two-week cadence and the design history file has to stay current. How do you make both work?

What they are checking: Whether they can keep design records current in a fast agile cadence, building quality into the workflow instead of slowing releases.

The posting asks for a bachelor's with six years, a master's with five, or a doctorate with none, at North Chicago. Where do you sit, and what would you want to know about the products before you took it?

What they are checking: Whether they know where they fit the stated requirements and ask about the products and team, showing realistic interest in this specific role.

About the work

This role represents quality on software as a medical device and digital health product teams. What software medical device work have you done?

What they are checking: Whether they have real software medical device experience, since this differs from traditional device quality in pace, risk and documentation.

You'd perform design control and risk management including cybersecurity risk. Walk me through risk management for a piece of medical software.

What they are checking: Whether they can run risk management for medical software, including cybersecurity, tying hazards to controls and verification in a traceable way.

The posting names computer software assurance and good automated manufacturing practice principles for validation. How do those change how much you test?

What they are checking: Whether they understand risk-based validation and can scale testing to real risk, rather than testing everything equally or documenting for its own sake.

It names the software lifecycle standard, the risk management standard, the design control regulation and the European device regulation. Which do you know best, and where do they pull against each other?

What they are checking: Whether they know the main software device standards deeply enough to spot where they conflict, which shows real working experience with them.

You'd support corrective and preventive action including root cause analysis and effectiveness checks. What makes an effectiveness check meaningful?

What they are checking: Whether they design effectiveness checks that prove a problem stopped recurring, rather than only confirming that the corrective action was completed.

You'd support regulatory agency and internal audits. What does an inspector look for in a design history file?

What they are checking: Whether they know what inspectors look for in a design history file, such as traceability and complete verification, before an audit arrives.

Practice this interview out loud.

Offer builds a real interview for this exact role at AbbVie from your resume and this job description, asks the questions one at a time, and tells you what landed. The first one is free.

Practice this out loud

The full job description

As published by AbbVie.

The Lead Digital Health Quality Engineer will serve as representative on cross-functional SaMD and Digital Health Software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional collaboration skills. Responsibilities: • Responsible for compliance with applicable Corporate and Divisional policies, procedures, and global regulations governing Digital Health applications and SaMD, including AbbVie's software lifecycle requirements, using standard methodologies, processes, and tools. • Perform design control and risk management activities (including cybersecurity risk management) per AbbVie's Quality System, partnering with technical teams to ensure design control documentation (risk management, traceability/linkages) and design change control requirements are met. • Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities. • Write/review processes, procedures, and related documents for the development of SaMD and Digital Health products in compliance with global regulations. • Support the creation of regulatory submission documentation. • Support Corrective and Preventive Action (CAPA) activities related to SaMD and Digital Health quality issues, including root cause analysis, effectiveness checks, and closure. • Assist in the preparation of, and support, regulatory agency and internal audits. • Lead and actively participate in continuous improvement initiatives — including within the Design History File and Risk Management — anticipating and resolving quality issues, taking preventative action, and tracking improvements to closure. • Serve as a subject matter expert on SaMD/Digital Health quality and regulatory requirements across cross-functional teams. • Communicate SaMD/Digital Health project and quality status through timely, accurate reports to project teams, and management, and recommend actions to resolve emerging issues. • Initiate assignments independently, exercising considerable latitude in determining objectives and approach. Required: • Bachelor’s Degree with 6 years of experience; or Master’s Degree with 5 years of experience;or PhD with 0 years of experience. • Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills. • Experience in a quality systems environment, or equivalent combination of work experience; excellent analytical, judgment, and consultative capabilities; and strong communication skills with the ability to work effectively with cross-functional teams. • Exercises considerable latitude in determining the objectives of and approach of assigned work. • Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR. • Experience with creation and maintenance of QMS documents for development of medical devices. Preferred: • Familiarity with medical device cybersecurity; AI/ML; Connected devices; Digital Health emerging Technologies; AI/ML awareness is a plus. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​ • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ • This job is eligible to participate in our short-term incentive programs. ​ Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​ AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Apply at AbbVie