Lead SaMD Quality Engineer - Digital Health & Regulatory

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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The LeadDigital HealthQuality 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 thesoftware life cycle. This role will Author,review, and approve QMS and project documentation — including risk management files — toensure products are developed, tested, and released in compliance withapplicableSDLCprocedureand/ormedicaldevice regulations. This role will lead quality process improvement initiatives, support regulatorycharacterization 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.
• Experiencewith 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.
• SupportCorrective and Preventive Action (CAPA) activities related to SaMD and Digital Health quality issues, including root cause analysis, effectiveness checks, and closure.
• Assistin the preparation of, and support, regulatory agency and internal audits.
• Lead and activelyparticipatein continuous improvement initiatives — including within the Design History File and Risk Management —anticipatingand 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.
• CommunicateSaMD/Digital Health project and quality status throughtimely,accuratereports to project teams,andmanagement, and recommend actions to resolve emerging issues.
• Initiate assignments independently, exercising considerable latitude in determiningobjectivesand approach.

Qualifications

Required:

• Bachelor’s Degree with 6 yearsofexperience;or Master’sDegree with 5 yearsofexperience;orPhD with 0 yearsofexperience.
• Experience in coordination and planning of complex activities andabilitytoidentifyand resolve complex problems through effective use of technical and interpersonal skills.
• Experience in a quality systems environment, or equivalent combination ofwork experience; excellent analytical, judgment,and consultative capabilities;andstrongcommunicationskillswiththe ability to workeffectivelywithcross-functional teams.
• Exercises considerable latitude indeterminingtheobjectivesof and approach of assigned work.
• Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR820.30and EU MDR.
• Experience with creation and maintenance of QMS documents fordevelopmentof medical devices.

Preferred:

• Familiaritywithmedical device cybersecurity; AI/ML; Connected devices; Digital Healthemerging Technologies; AI/ML awarenessis a plus.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable 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.

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