Medical Device Quality Manager - Software (SaMD/SiMD)

AbbVie • North Chicago, IL

303d

About The Position

The Manager, Medical Device Quality - Software will act as the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Key responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and CAPA, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. This position will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality. This position will be located at our Medical Device Center Headquarters in Waukegan, IL and report directly into the Senior Manager of Medical Device Quality.

Requirements

• Bachelor's degree in science, engineering, or other technical areas; Advanced degree preferred; ASQ certification preferred.
• 7+ years of relevant experience in the medical device industry; experience with SaMD, SiMD, infusion pumps and supporting ecosystems preferred.
• 5+ years of Quality Assurance experience required.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).
• Working knowledge of international standards applicable to medical devices.
• Ability to apply practical and technical problem solving to quality system and product improvements.
• Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
• Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
• Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.
• Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the AbbVie's environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work in a fast-paced environment.
• Able to travel up to 10% of the time.

Responsibilities

• Leads resolution of quality issues with on-market device software & mobile apps.
• Drives investigations related to product nonconformities.
• Define and implement corrective and preventive actions.
• Serves as the Quality approver of any device software or mobile app complaints and complaint trend evaluations.
• Serves as the Quality reviewer and approver of device software design control tasks or IT change requests in Service Now for device software and mobile apps.
• Serves as the Device QA approver of post-market surveillance and clinical evaluation plans and reports for SaMD/SiMD products.
• Serves as the Medical Device Quality SME on software classification review board.
• Support risk management / FMEA activities for device software & mobile apps.
• Drive change management process for device software / mobile app launches and market expansions.
• SaMD/SiMD SME for regulatory / notified body inspections as needed.
• Lead SaMD/SiMD Quality Management System and Digital Health initiatives.
• Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities.
• Implements agreed strategy.
• Makes recommendations for key decisions on products in scope.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree