Lead Digital Health Quality Engineer

BioSpace; North Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

PTO

Medical insurance

401(k)

Job summary

AbbVie in the United States is seeking a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management (IEC 62304/ISO 14971) across the Software Life Cycle for SaMD and Digital Health products.

You will author, review, and approve QMS and project documentation, support regulatory submissions and audits, lead CAPA activities, and collaborate across cross-functional teams to ensure development and release in compliance with global

Qualifications

• Bachelor's degree with 6+ years experience or Master’s with 5+ years or PhD with 0 years.
• Experience in quality systems environment and cross-functional collaboration.
• Strong understanding of IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
• Experience creating and maintaining QMS documents for medical devices.

Responsibilities

• Ensure compliance with policies, procedures, and global regulations for Digital Health apps and SaMD.
• Perform design control and risk management activities per Quality System.
• Lead and participate in continuous improvement, CAPA, audits, and regulatory support.
• Lead and write processes and documentation for SaMD and Digital Health products.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

SDLC

Regulatory submissions

Risk management

Cybersecurity risk

Design controls

QMS documentation

Education

Bachelor's degree in related field

Master's degree

PhD

Tools

GAMP5

CSA

Cybersecurity tools

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 about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company 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 about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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 characterisation 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.

Qualifications

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.

Additional Information

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 employer 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