Medical Device Quality Manager - Software SaMDSiMD

The Manager Medical Device Quality Software will act as the global product quality lead in support of a broad portfolio of onmarket medical devices including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Key responsibilities include crossfunctional correspondence quality management reviews audit support change planning and CAPA with oversight of complaint trending postmarket 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 onmarket 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.

• Leads resolution of quality issues with onmarket 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 postmarket 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 Heath 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

Qualifications :

• Bachelors 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 IECCFR 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 crossculturally and crossfunctionally.
• Proven ability to effectively lead crossfunctional 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 riskbased decision making; Ability to understand the sensitivities within the AbbVies environment.
• Excellent project management and interpersonal skills
• Adaptable to changes in work environment
• Ability to work in a fastpaced environment
• Able to travel up to 10 of the time.

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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

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