Lead Digital Health Quality Engineer

Regulatory Jobs; Chicago (IL); Presencial; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO

Medical insurance

401(k)

Incentives

Descripción de la vacante

AbbVie in the United States invites a Lead Digital Health Quality Engineer to lead design controls, risk management, and software validation for SaMD and Digital Health products, ensuring compliance with IEC 62304, ISO 14971, 21 CFR 820.30, and EU MDR across the software life cycle.

You will author and review QMS documents, support regulatory submissions and audits, lead CAPA activities, and collaborate with cross‑functional teams to drive quality improvements, cybersecurity considerations, and

Formación

• 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 coordinating complex activities and resolving problems through technical and interpersonal skills.
• Experience in a quality systems environment; analytical, judgmental, and communication skills; cross-functional teamwork.
• Exhibits latitude in determining objectives and approach.
• Strong understanding of IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
• Experience creating and maintaining QMS documents for medical devices development.

Responsabilidades

• Ensure compliance with global regulations governing Digital Health apps and SaMD, including software lifecycle requirements.
• Perform design control and risk management activities per Quality System, partnering with technical teams.
• Experience with CSA and GAMP5 principles for software validation and lifecycle activities.
• Write/review SaMD and Digital Health development documents in compliance with global regulations.
• Support regulatory submission documentation and audits.
• Lead CAPA activities and root-cause analysis for SaMD quality issues.
• Lead continuous improvement initiatives within Design History File and Risk Management.
• Serve as SME on SaMD/Digital Health quality and regulatory requirements across cross-functional teams.
• Communicate project and quality status through timely reports and recommendations.

Conocimientos

Quality systems

Design controls

Risk management

Regulatory knowledge

CSA & GAMP5

Cross-functional collaboration

Educación

Bachelor’s Degree

Master’s Degree

PhD

Descripción del empleo

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