Lead Digital Health Quality Engineer

Regulatory Jobs; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Paid time off

Job summary

AbbVie is seeking a Lead Digital Health Quality Engineer to drive design controls, risk management, software validation, and regulatory submissions across SaMD and Digital Health products. You will author and review QMS documentation, lead quality improvements, and collaborate with cross-functional teams to ensure compliance with IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.

You will guide lifecycle activities, support audits, and contribute to cybersecurity quality programs while coordinating

Qualifications

• Experience in a quality systems environment and cross-functional teamwork.
• Ability to author and review QMS documentation for SaMD and Digital Health.
• Knowledge of SDLC, design controls, risk management, and regulatory submissions.

Responsibilities

• Ensure compliance with corporate/divisional policies and global regulations for Digital Health and SaMD.
• Lead design controls and risk management activities, including cybersecurity risk management.
• Contribute to software validation and lifecycle activities per CSA and GAMP5.
• Write/review processes and documents for SaMD and Digital Health product development.
• Support regulatory submissions and CAPA activities related to quality issues.
• Lead continuous improvement initiatives in Design History File and Risk Management.

Skills

Quality engineering

Regulatory compliance

Design controls

Risk management

Cybersecurity risk management

GAMP5

IEC 62304

ISO 14971

21 CFR 820.30

EU MDR

Education

Bachelor’s degree

Master’s degree

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

Role Overview

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.

Compensation & Benefits

• The compensation range 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 will depend on many factors including geographic location.
• 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.

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: https://www.abbvie.com/join-us/reasonable-accommodations.html