Lead Digital Health Quality Engineer

About the role

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.

Qualifications & Requirements

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 employee 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.