Lead Digital Health Quality Engineer

• Compensation: USD 96500 - USD 183500 - yearly

About Abb Vie

Abb Vie'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 Abb Vie, please visit us  .

Follow @abbvie onLinked

In, Facebook ,Instagram ,X and YouTube.

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 —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 Abb Vie's software lifecycle requirements, using standard methodologies, processes, and tools.
• Perform design control and risk management activities (including cybersecurity risk management) per Abb Vie'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.
• 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 —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 determiningobjectivesand approach.

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…